The Comparative Efficacy of Conventional Short-Stretch Multilayer Bandages and Velcro Adjustable Compression Wraps in Active Treatment Phase of Patients with Lower Limb Lymphedema

Abstract

Background:

Compression is the most important component of complete decongestive therapy (CDT), but there is no standard best method for applying compression. The aim of this study was to evaluate the comparative efficacy of conventional multilayer short-stretch bandaging, and a velcro adjustable compression wrap with regard to volume reduction, ultrasonographic measurements, functional-status, and quality of life (QoL) in the active CDT period of patients with lower limb lymphedema.

Methods and Results:

The demographic and clinical variables of lower limb lymphedema patients were recorded. All patients received skin care education, manual lymphatic drainage, and supervised lyphedema exercises, and were randomly allocated to Group1 (multilayer short-stretch bandaging-Rosidal-K^®) or to Group 2 (adjustable-compression-velcro-wrap-Circaid Reduction-kit^®) for a duration of 3 weeks with 15 sessions. Limb volumes were assessed by perometer. Ultrasonographic measurements included subcutaneous soft tissue thickness. The functional disability and QoL were evaluated by the Lower Extremity Functional Scale and LYMQOL-Leg (Lymphedema Quality of Life Questionnaire-Leg), respectively, at baseline, after CDT, and at first-month follow-up. Thirty-six patients (10 male and 26 female) with mean age of 51.6 ± 11.7 years were included. Fourteen patients had primary and 22 patients had secondary lymphedema. The median duration of lymphedema was 68 months. Significant improvements in volumes and ultrasonographic measurments were observed in both groups at the end of therapies, and improvements sustained up to a month. Appearance, symptoms, and overall QoL-subscores were improved only in Group 2.

Conclusion:

In conclusion, adjustable compression velcro-wrap performed as a part of CDT can greatly reduce the volume similiar to conventional multilayer bandages, as well as improve the QoL. It can be a comfortable alternative to the conventional multilayer bandages in the active treatment phase of the CDT.

Introduction

Lymphedema is a chronic condition characterized by swelling of a body part due to compromised lymphatic system. Lymphedema is commonly seen in lower extremities and can be diagnosed as primary or secondary lymphedema. Primary lymphedema is caused by congenital abnormality or dysfunction in the lymphatic system; while secondary lymphedema develops after acquired causes comprising trauma, reccurrent infection, or mostly carcinoma or its treatment.^1,2 Recent studies have enlightened the extent of the problem that lower limb lymphedema may be present in 33% and 45% of the patients treated for pelvic organ cancer.³ The incidence of primary lymphedema is much more less, but both types of lower limb lymphedema have a major impact on the patients' physical and psychosocial status, and quality of life (QoL).⁴

The treatment of lymhpedema mainly aims to reduce and maintain the limb size, to prevent the complications and progression of disease, and to improve physical and psychosocial QoL. Complete decongestive therapy (CDT), which combines skin care, manual lymphatic drainage (MLD), multilayer bandaging, compression garments, and exercises, is currently recognized as the standard lymphedema treatment and comprises two phases. Compression of the extremity by bandaging is essential in the phase-1 treatment of lymphedema, as it reduces the edema and limb size before the application of compression stockings that are needed in the maintanence phase.^5,6

Different bandaging systems consisting of conventional short-stretch bandages, Coban 2-layer bandages, and Mobiderm bandages are available over the counter for the intensive phase of the CDT.^7–10 Compression in the intensive phase of CDT is not standardized, but multilayer short-stretch bandages are currently the most well-known option for compression therapy. The application of these conventional bandages may be time-consuming due to the multilayer nature and short daily intervals, and need a lymphedema specialist. It may also restrict the function of the lower extremity beacuse of the coarse contexture of the bandages. The introduction of nonelastic adjustable velcro compression wrap devices brought several advantages consisting of comfortness, lightness, availability of variants for shape distorsions, and easy to self-manage.^9–13 These systems can effectively decongest the extremity and be used in both active and maintenance phases of CDT.^{11,12,14–16}

The utilization of this compression system based on adjustable velcro bands, presented the oppurtunity to compare the efficacy of conventional multilayer bandages and/or compression garments, and this new system. The comparative effectiveness of velcro adjustable nonelastic compression devices with conventional compression systems in treatment of venous edema and venous ulcers has been studied before,^{9,10,12,14,16} but few studies have been performed to evaluate the effectiveness of velcro adjustable nonelastic wrappings in patients with lymphedema.^{11,15,16–18} Most of these limited studies are performed on patients with upper lymphedema,^17,18 two are case reports^15,16 and all, but one,¹¹ studies related with lower extremity lymphedema were held in the maintenance phase of CDT.^15,16–18

The aim of this study was to evaluate the comparative efficacy of conventional multilayer short-stretch bandages (Rosidal K^®) and a nonelastic adjustable velcro compression wrap (Circaid Reduction-kit^®) with regard to volume reduction, ultrasonographic measurements, functional status, and QoL in a group of patients with lower limb lymphedema.

Materials and Methods

This prospective randomized single-blind study was approved by the local ethics committee University of Hacettepe (Project GO19/377) and written informed consent was obtained from all participants. The study was conducted in accordance with the principles of Declaration of Helsinki. Power analysis during the biostatistical preliminary assesment indicated a study population of 38 patients (19 patients for each group) with a power level of 80% and 5% error margin.

Recrıitment to the study

Patients who had submitted to the lymphedema unit for lower limb lymphedema were enrolled to the study between January 2019 and August 2019. The inclusion criteria were as follows: (1) age between 18 and 65, (2) having unilateral lower extremity lymphedema, (3) complied to and fully attended intensive CDT sessions (skin care, MLD, bandaging [conventional short-stretch multilayer/Circaid Juxtafit], and lymphedema exercises) for 3 weeks and come to first-month control visit, and (4) having completed chemotherapy and/or radiation therapy, if they have secondary lymphedema due to cancer treatment. Patients were excluded according to the following criteria: (1) patients with history of contralateral lower leg edema, (2) medical history comprising other causes of leg edema than lymphedema, (3) having recurrence or metastasis in patients having lymphedema secondary to cancer treatment, (4) having contraindicated condition for CDT (renal insufficiency, congestive heart failure, infection, thrombosis, thyroid or abdominal disease, severe vascular disease, etc.), (5) having had any prior therapy for lymphedema, and (6) immobile patients or patients with hip/knee pathology, and patients with cognitive or neurological disorder. All patients had received therapies as an outpatient basis.

Demographic and clinical data

Demographic and clinical properties comprising age, gender, body mass index (BMI), education, occupation, regular exercise habit, and smoking were recorded. Lymphedema characteristics, including duration of lymphedema, etiology and cause of lymphedema, stage of lymphedema according to ISL² classification, and positivity of Stemmer sign, were assessed.

Assessment of lymphedema

The presence of lymphedema was assessed by interlimb volume difference based on the serial circumferential measurements in both affected and nonaffected extremities. The clinical diagnosis of lower limb lymphedema was defined as an interlimb difference of >10% in volume or excess volume ratio between the affected and nonaffected limbs.^1,19

Volume measurements

Limb volume was measured using an optoelectronic perometer (Pero-System^® 350 NT Messgeräte GmbH, Wuppertal, Germany), which was connected to a personal computer. For measurement, the patient sat on the seat of the perometer with one limb inside and the other outside the frame. Infrared light transmitters located on two sides of the frame project light toward photosensors on the opposing two sites, and the limb effectively blocks transmission of the light from one side of the frame to the other, creating an electronic image. As the frame is moved along the limb, a series of images are recorded every 0.5 cm, creating limb size and volume on the computer using the Peroplus 2000 Software (Pero-System Messgeräte GmbH). Computer software allowed for the analysis of volume and excess volume at any stage of measurement. For each patient, limb volume was measured pretreatment, posttreatment, and at follow-up 1 month after the treatment. Every patient was assessed by the same researcher blinded to the group of the patients (A.Y.).

Ultrasonographic measurements

The ultrasonographic measurements included measurements of subcutaneous skin thicknesses that were assessed in the affected lower extremities. A 5- to 12-MHz linear array probe (Logiq P5; GE, Medical Systems) was used to obtain cross-sectional images of the soft tissue subcutis thickness at four standardized points defined as follows: (1) anterior thigh; the midpoint between the hip joint and patella on the midline, (2) anterior leg; the midpoint between the patella and ankle as the line between lateral and medial malleolus, (3) posterior thigh; the midpoint between the gluteal area and popliteal fossa on the midline, and (4) posterior leg; the midpoint between the popliteal fossa and ankle as the posterior midline between lateral and medial malleolus.^20,21 During each ultrasonographic (US) measurement, patients lay down on the examination table in a supine position. A standard amount of US gel was used. The measurements of subcutaneous tissue thicknesses on determined points were performed without any pressure. All of the US measurements were performed by the same blinded researcher (E.G.K.) at baseline, after treatment, and at follow-up-1 month after the treatment.

Functional status

Functional disability of the affected extremity was evaluated by the Turkish version of the Lower Extremity Functional Scale (LEFS).²² The LEFS has 20 items in 4 categories and assesses the difficulties in carrying out routine activities in, around, and out of the home. For each question, 0 to 4 points can be earned, and so, 80 points as a total indicate maximum lower extremity function.²³

QoL assessment

QoL was assessed by the Turkish version of Lymphedema Quality of Life Questionnaire-Leg (LYMQOL-Leg).²⁴ The LYMQOL-Arm has been developed by Keeley et al. to assess the impact of lymphedema of the legs on the QoL of the patients. It consists of 4 domains with 28 items. These domains are function, appearance, symptoms, and mood. The answers were evaluated on a 4-point Likert scale (1 = not at all, 2 = a little, 3 = quite a bit, 4 = a lot). Each item received a score between 1 and 4, with higher scores indicating a worse QoL. Also, there is an overall QoL rating. The “overall QoL” item was scored 0–10.²⁵ QoL and functional status assessments were performed by the same researcher (A.Y.) at baseline, after CDT, and at follow-up 1 month later.

Randomization and assignment to groups

Patients were randomly allocated to Group 1 (skin care, MLD, traditional multi layer short-stretch bandaging (Rosidal K), and lymphedema exercises) or to Group 2 (skin care, MLD, and adjustable velcro-wrap-Circaid Reduction-kit and exercises), which was applied five times per week for 3 weeks. Randomization was provided with a sealed envelope method.

Complex decongestive therapy (CDT)

All patients were educated for skin care and maintenance of healthy body weight and delivered a written brochure for general advice in the first visit by the same lymphedema physiotherapist (E.C.). The patients received MLD for a period of 45 minutes according to the Vodder Technique, performed in a proximal to distal direction with light skin strokes (stationary circle, rotary, pump, and scoop techniques), covering the cervical area, abdominal area, anterior trunk, and posterior trunk anastomoses and the whole limb.²⁶ All the patients received MLD from the same experienced and certified physiotherapist (E.C.).

After the MLD, Group 1 received nonelastic short-stretch multilayer bandages (Rosidal-K) that were applied and changed daily except the weekends. A cotton tube stockinet was placed on the foot first, and then, finger bandaging was applied. A layer of cotton padding bandage was placed on the foot and wrapped around the foot and all through the limb. Four types of short-stretch bandages (6, 8, 10, 12 cm in width) were sequentially placed around the limb with the first starting at the foot, the second at the ankle, and the third and fourth starting below the ankle and up to the inguinal area. Multiple layer compression bandages were applied such that the most compression was at the distal parts and the compression decreased gradually moving to proximal sites.²⁷

Group 2 received velcro-adjustable-compression-wrap-Circaid Reduction-kit (Medi GmbH, Bayreuth, Germany) according to the manufacturer's instructions. After measuring the leg, the nonelastic adjustable garment-Circaid was trimmed to fit the patient, After wearing lower undersleeve, the lower leg, knee, and upper leg parts were applied. The correct therapeutic tension range was controlled by a built-in tension system. As the limb volume reduced, the garment was customized. All of the conventional bandages were applied by the same experienced physiotherapist (R.S.) and all the Circaid wrapping devices were performed by the same experienced physiotherapist (F.K.).

All subjects were provided an individualized active exercise program after bandaging under the supervision of the same experienced physiotherapists (R.S. and F.K.). The exercises included abdominal breathing exercise, low-back and hip stretching, pumping, and nonisometric strengthening of leg muscles to help facilitate lymphatic flow and improve strength and range of motion.²⁸ The exercises were performed within the bandages, for a duration of 20 minutes.

Maintenance phase

After the intensive CDT period, all patients were prescribed pressure garments with CCL 3 pressure, and instructed to wear the garment daily (removed at night). They were instructed to perform self-MLD and self-exercises (with garment) at least three times per week for 20 minutes and delivered printed materials for self-management. The compliance to the second phase of CDT was measured with a questionnaire evaluating the interval and duration of self-MLD (regularly performed at least three times/week; skipped-performed less than three times/week; not performed) and self-exercises (regularly performed at least three times/week; skipped-performed less than three times/week; not performed), as well as the duration of wearing pressure garments (all day; half a day; less than half a day; not at all) for all patients.

Outcome measures

The primary outcome measures were determined as lower extremity excess volumes and percent changes of excess volumes. The secondary outcomes included improvement in functional status, QoL scores, and ultrasonographic measurements, which were evaluated at baseline, after 3 weeks of intensive treatment period, and at first-month control follow-up in all patients.

Statistical analysis

Statistical analysis was performed with IBM SPSS for Windows Version 23.0 software. Numerical variables were expressed as mean ± standard deviation or median [min–max] as appropriate. Categorical variables were summarized as numbers and percentages. Normallity of the continuous variables was tested by the Shapiro–Wilks test. The Levene test was used to show the homogeneity of variances. Continuous variables were compared by the independent samples t-test or Mann–Whitney U test as appropriate. Categorical variables were compared by the chi-square test or Fisher exact test. Repeated-measures ANOVA was performed to show between- and within-group differences. Pairwise comparisons were performed by the Bonferroni test. A p-value <0.05 was considered statistically significant.

Results

In our study, 78 lower limb lymphedema patients, who referred to the lymphedema unit between January 2019 and August 2019, had been evaluated according to the eligibility criteria. Ten patients were excluded for comorbid diseases and 18 patients had bilateral lymphedema, and 1 patient had metastases of endometrium cancer. Nine patients did not agree to take part in the study due to different reasons (transportation difficulties, could not afford the costs of bandages and/or pressure garments, their schedule was not suitable for the treatment periods). Three patients did not comply with the self-management procedures during the maintenance period. One patient did not come to the follow-up. Therefore, data of 36 patients were included to the analysis. The flowchart of the study is shown in Figure 1.

FIG. 1.

The flowchart of the recruitment of participants to the study.

The demographic features and clinical properties of the patients are shown in Table 1. There were 10 male and 26 female patients with a mean age of 51.6 years. Most of the patients were overweight and obese and the mean BMI was 29 kg/m². In both groups, none of the patients regularly exercised and the majority of them were nonsmoking. Approximately more than half of the patients graduated from high school and university. Female patients were commonly housewives. Concerning the etiology of lymphedema, 14 patients had primary and 22 patients had secondary lymphedema, mostly due to cancer treatment. Regarding lymphedema, the median duration of lymphedema was 120 and 30 months in Groups 1 and 2, respectively. The majority of the participants had grade 2 lymphedema according to ISL staging. Stemmer sign was positive in most of the patients, indicating the involvement of feet. The lymphedema characteristics of the patients are shown in Table 1. No significant differences with regard to lymphedema properties and demographic characteristics were found between the two groups.

Table 1.

The Demographical and Clinical Characteristics of the Patients According to Study Groups

	Group 1, n = 19	Group 2, n = 17	p
Age, years, mean ± SD	52.74 ± 18.74	51.38 ± 13.86	0.812
BMI, kg/m², mean ± SD	29.46 ± 6.78	29.60 ± 4.80	0.947
Gender
Female	15	11	0.700
Male	4	6
Education, n (%)
Illiterate	1 (5.3)	1 (5.8)	0.669
Primary school	7 (36.8)	8 (47)
High school	7 (36.8)	4 (23.5)
University	4 (21.1)	4 (23.5)
Occupation, n (%)
Housewife	8 (42.1)	10 (58.8)	0.560
Officer	3 (15.8)	3 (17.6)
Retired	2 (10.5)	2 (11.7)
Other	6 (31.6)	2 (11.7)
Exercise habit, n (%)
Yes	0	0
No	19 (100)	17 (100)
Smoking, n (%)
Yes	2 (10.5)	1 (5.8)	0.502
No	15 (78.9)	12 (70.5)
Exsmoker	2 (10.5)	4 (23.5)
Duration of lymphedema, mean ± SDMedian, months	131.5 ± 116.2120	86.81 ± 99.3230	0.164
Cause of lymphedema, n (%)
Primary	7 (36.83)	7 (41.1)	0.945
Secondary	12 (63.2)	10 (58.8)
Cancer treatment history, n (%)
Yes	8 (42.1)	5 (29.4)	0.481
No	11 (57.9)	12 (70.6)
Stage of lymphedema (ISL), n (%)
Stage 1	2 (10.5)	1 (6.3)	0.898
Stage 2	16 (84.2)	14 (87.5)
Stage 3	1 (5.3)	1 (6.3)
Stemmer sign, n (%)
Positive	16 (84.2)	15 (88.3)	1
Negative	3 (15.8)	2 (11.7)

BMI, body mass index; SD, standard deviation.

The difference in volumes and excess volumes, which were evaluated at baseline, after CDT, and first-month follow-up, is shown in Table 2. At baseline evaluation, there were no differences between the study groups in terms of volumes and percentage excess volumes. The volumes and excess percentage volumes were significantly decreased after CDT in both groups. The improvements were similar between the groups and sustained at the first-month follow-up.

Table 2.

The Volume Differences and Excess Volume Measurements Before and After the Treatments and at First-Month Follow-Up Control

	Before therapy	After therapy	First-month control	Intragroup p-values
				Overall	Before-after	Before control	After control
Volume differences in perometry measurement, cm³, mean ± SD
Group 1	2247.5 ± 1769.5	1315.6 ± 1168.8	1312.3 ± 1209.9	0.202	0.003	0.001	1
Group 2	3234.5 ± 2415.6	1347.2 ± 852.6	1298.3 ± 1019.5	0.000
p-Value between groups	0.331	0.944	0.978
Excess volume in perometry measurement, %, mean ± SD
Group 1	25.5 ± 15.8	16.4 ± 13.6	15.5 ± 11.7	0.013	0.014	0.009	1
Group 2	30.1 ± 17.4	15.6 ± 11.4	15.6 ± 11.7	0.000	0.000	0.000	1
p-Value between groups	0.550	0.894	0.977

Functional status indicated by the LEFS scores and the QoL scores evaluated by LYMQOL-Leg are shown in Table 3. The baseline scores of LEFS and subgroups of LYMQOL-leg were similar between the groups. The mean value of LEFS scores was increased after CDT and at follow-up, but did not reach significance in both groups. The baseline QoL scores assessed by LYMQOL-leg were statistically similar between the groups. There were significant improvements in the mean scores of QoL-subgroups in both groups, but reached to be statistically significant in symptom, appearance, and overall subgroup scores of patients in Group 2. The statistically significant improvements were sustained at the follow-up control in this group.

Table 3.

The Lower Extremity Functional Scale Scores and Quality-of-Life Scores of the Groups Before and After the Treatment and at First-Month Control

	Before therapy	After therapy	Control	Intragroup p-value
LYMQoL-Leg
Function
Group 1	2.29 ± 0.88	2.13 ± 0.88	2.04 ± 0.94	0.520^a
Group 2	2.25 ± 0.84	2.05 ± 0.51	2.02 ± 0.49	0.341^b
p-Value between groups	0.912	0.798	0.942
Appearance
Group 1	2.25 ± 0.58	2.14 ± 0.57	2.08 ± 0.60	0.629^a
Group 2	2.65 ± 0.71	2.48 ± 0.56	2.09 ± 0.73	0.009^b
p-Value between groups	0.184	0.181	0.977
Symptom
Group 1	2.31 ± 0.84	2.24 ± 0.87	2.27 ± 0.70	0.943^a
Group 2	2.45 ± 1.04	2.00 ± 0.46	1.86 ± 0.49	0.050^b
p-Value between groups	0.750	0.401	0.126
Emotion
Group 1	2.02 ± 0.66	2.00 ± 0.72	1.87 ± 0.69	0.542^a
Group 2	2.37 ± 0.48	2.50 ± 0.57	2.27 ± 0.64	0.091^b
p-Value between groups	0.161	0.084	0.178
Overall
Group 1	5.55 ± 1.94	6.22 ± 1.92	6.44 ± 1.88	0.127^a
Group 2	5.54 ± 1.39	6.00 ± 1.22	6.46 ± 1.33	0.050^b
p-Value between groups	0.981	0.743	0.980
LEFS
Group 1	0.5610	0.6375	0.6891	0.120^a
Group 2	0.5635	0.6146	0.6542	0.208^b
p-Value between groups	0.982	0.830	0.734

Before and after therapy and control for Group 1.

Before and after therapy and control for Group 2.

LEFS, lower extremity functional scale; LYMQoL-Leg, Lymphedema Quality of Life Questionnaire-Leg.

The US measurements that were performed at baseline, after CDT, and at the first-month follow-up are shown in Table 4. The subcutaneous thickness scores in all predetermined points were decreased after the treatment period in both groups and improvements were statistically similar between the groups, and sustained at the first-month follow-up in all groups (Table 4).

Table 4.

The Ultrasonographic Variables Before and After the Treatments and at First-Month Follow-Up Control

Subcutaneous tissue thickness	Before therapy	After therapy	Control	Intragroup p-value
Subcutaneous tissue thickness				Overall	Before-after	Before control	After control
Anterior thigh
Group 1	2.28 ± 1.08	2.21 ± 1.06	2.11 ± 1.12	0.185
Group 2	2.16 ± 0.92	1.67 ± 0.91	1.83 ± 0.83	0.000	0.003	0.002	0.754
p-Value between groups	0.772	0.207	0.511
Posterior thigh
Group 1	2.09 ± 0.68	1.82 ± 0.62	1.94 ± 0.68	0.477
Group 2	1.73 ± 1.15	1.83 ± 1.05	1.86 ± 1.08	0.866
p-value between groups	0.392	0.977	0.856
Anterior leg
Group 1	1.84 ± 1.12	1.55 ± 0.66	1.32 ± 0.68	0.029	0.432	0.027	0.331
Group 2	2.13 ± 1.06	1.58 ± 0.75	1.66 ± 0.87	0.017	0.015	0.030	1
p-Value between groups	0.542	0.927	0.321
Posterior leg
Group 1	1.77 ± 0.79	1.31 ± 0.49	1.42 ± 0.67	0.012	0.008	0.112	1
Group 2	1.77 ± 0.93	1.54 ± 0.77	1.30 ± 0.96	0.013	0.189	0.009	0.200
p-Value between groups	0.997	0.431	0.754

The correlation between volume reduction and demographical variables was only indicated in BMI (p = 0.019, r = 0.439) and education level (p = 0.010, r = 0.479) of the participants. There were also significant relationships between volume reduction rate and improvements in US variables and QoL subscores in the whole group (Table 5).

Table 5.

The Correlation Coefficients Between Volume Reduction Assessed by Perometric Measurements and Improvements in Ultrasonographic and Quality-of-Life Subgroup Scores

	Volume reduction
Improvement of QoL-Function	r = 0.422
Improvement of QoL-Function	p = 0.032
Improvement of QoL-Appearance	r = NS
Improvement of QoL-Appearance	p = NS
Improvement of QoL-Symptom	r = 0.422
Improvement of QoL-Symptom	p = 0.024
Improvement of QoL-Emotion	r = NS
Improvement of QoL-Emotion	p = NS
Improvement of QoL-Overall	r = NS
Improvement of QoL-Overall	p = NS
Improvement of subcutaneous tissue thickness in anterior thigh	r = 0.402
	p = 0.047
Improvement of subcutaneous tissue thickness in posterior thigh	r = 0.521
	p = 0.009
Improvement of subcutaneous tissue thickness in anterior leg	r = 0.482
	p = 0.017
Improvement of subcutaneous tissue thickness in posterior leg	r = 0.414
	p = 0.036

NS, not statistically significant (p > 0.05).

QoL, quality of life.

Discussion

Compression is the most important component in both phases of CDT in the management of venous and lymphatic disorders. Compression bandages that are used in the active phase of CDT are classified according to their ability to apply a sub-bandage pressure and stiffness, but there is no standard best method for applying compression.^7,11,15

Gradient compression is important for improved venous return and reduction in the size of leg edema.^7,9 Previous studies indicated that inelastic adjustable compression garments produced significant ankle/knee gradient compression.^7,9,13,14 The inelastic leggings may have a therapeutic advantage over the multilayer bandages as they are adjustable and can provide higher reductions in volume accordingly. Benigni et al.¹² indicated a gretaer reduction in leg volumes of 28 mobile nursing home patients, just 2 hours after the application of Circaid Juxtafit than in wrapping with Rosidal K bandages. Mosti et al.¹⁴ observed a better volume regression by Circaid Juxtafit-device than in multilayer bandages after 1 week of application in 36 patients with stasis edema. The adaptive compression wrap was proved to be more effective and well tolerated by their patients. The comparative effectiveness of nonelastic adjustable compression garments with Unna boot or 4-layer elastic compression treatments in venous ulcers and edema has also been reported with a significantly faster healing rate, and greater reduction in edema with nonelastic garments than with the conventional multilayer compression system.^10,13 There are only few studies that have indicated the effects of velcro-adaptive compression devices in patients with lower extremity lymphedema.^11,15,16

Lund¹⁵ reported three cases of lower extremity lymphedema that have worn velcro-adaptive compression devices over the compression hosiery and determined steady improvements in volume reduction with increased QoL. These devices were reported to enhance the effect of standard compression garment hosiery.¹⁵ The comparative effectiveness of an adaptive compression device (Circaid Juxtafit) on compression stockings in a male patient with primary lymphedema was previously reported.¹⁶ The patient had received several CDT sessions after the liposuction surgery and prescribed different combinations of high-pressure class compression garments, but the maintenance of volume reduction could not be obtained until the addition of Circaid Juxtafit to the garment. Karafa et al.¹⁶ suggested that the added adjustable compression wrap was an effective alternative to compression garments with an increased mobility and comfortness. Damstra and Partsch¹¹ treated 30 lower lymphedema patients either with multilayer conventional bandages or with velcro-adaptive wraps and recorded similar volume reductions at 2 hours, but determined twofold more volume progression in the adaptive wrap group at the end of 24 hours.

To the best of our knowledge, our study is the first one in the literature that evaluates the comparative efficacy of conventional short-stretch bandages with velcro-adaptive systems with regard to not only the volume but also the ultrasonographic measures, and functional and QoL variables. Our findings demonstrate that the Circaid velcro-adaptive wrapping device has similar effects on the improvements of volume, functional status, and QoL in patients with unilateral lower leg lymphedema and the improvements were sustained up to first-month follow-up in both groups. In addition, same improvements were supported by the ultrasonographic measurements. Therefore, our results are consistent, but more detailed than the limited published studies in patients with lower limb lymphedema.

Lymphedema of lower extremities may lead to pain, limited joint activity and mobility, and impair the functional status and QoL.^1,3,4 Higher body weight may negatively affect the therapeutic improvement.³ Our study groups' mean BMI was relatively higher, but improvements with regard to limb volumes and ultrasonographic measurements were significant and similar between the study groups. We have recorded increased QoL subscores in both groups, but only the improvement in symptom, appearance, and overall subscores of the specific QoL instrument reached to be statistically significant in the adaptive velcro compression wrap group. Velcro-adaptive compression wrap devices are reported to be comfortable, are easy to put on and take off, and provide improved QoL and increased compliance, which support the results of our study.^9–11,15,16

We could not determine a relationship between functional scores and volume reductions in any of the groups. This may be due to the application of a functional disability instrument that is not spesific for lymphedema patients. The continuation of volume improvement to the first-month control was comparable between the groups and was supported by the ultrasonographic measurements. The educational level of the patients was correlated with volume reduction in all subjects. The sustainment of the improvements to the first month can be explained by the compliance of the patients to self-management techniques in the maintenance period, and may emphasize the importance of education and monitoring about self-management of lymphedema.

Ultrasonographic measurements are growing up in the diagnosis of lymphedema and monitoring the effects of treatments.^20,21,29,30 Lymphedema affects the skin and underlying tissues and previous studies suggested that US may provide information on the amount of subcutaneous fluid acumulation and can be used as a predictor of response to compression therapy in patients with lower extremity lymphedema.^20,21,29 Although the validity and reliability of US in identification and monitoring of lower extremity lymphedema have not been standardized, easy accessibility, cost-effectiveness, simplicity, and practicality of this method prompted its use as a new outcome measure.²⁰

There are few studies on the use of US measurement in assessing the response to CDT.^20,21,29 Yeo et al.²⁹ investigated the effects of 2-week CDT in 10 patients with lower extremity lymphedema by US and circumferential measurements. According to the results of this study, US evaluation was suggested to be performed in evaluating lymphedema and to be used as a sensitive indicator of therapeutic effects of CDT. Niimi et al.²⁰ examined the subcutaneous tissue changes by US in 178 patients with lymphedema and indicated that subcutaneous fluid accumulation imaging can be used as a predictor of good response for the treatment of lymphedema. Suehiro et al.²¹ assessed skin thickness, subcutaneous tissue thickness, and subcutaneous echogenicity in 35 patients with lower extremity lymphedema and found significant correlations with severity of lymphedema that is determined by ISL staging. Other studies also indicated that ultrasonographic subcutaneous thickness measurements were found to be sensitive for evaluating CDT efficacy in patients with lymphedema.³⁰

In our study, we have assessed the subcutaneous thickness in predetermined points of the affected limb and determined higher correlations with the perometric volume measurements before, after the CDT, and at first-month follow-up. There was a higher correlation between volume reduction and ultrasonographic subcutaneous thickness measurements. According to our results, subcutis thickness measurement using US seems to be a useful method in the assessment of the effectiveness of CDT not only in short term but also up to the first-month control. Considering the noninvasive and cost-effective properties of ultrasonography, we recommend more common use of US for evaluating treatment efficacy in patients with lower limb lymphedema. However, further studies with larger study groups and with different stages of lower limb lymphedema are needed to standardize the ultrasonographic assessment methods.

The limitations of our study are the relatively small size of the study group and lack of functional assessment instrument that is specific for lower leg lymphedema. However, the strengths of our study are the randomized single-blind type and the reliable outcome measures, which were assessed not only after the CDT but also at first-month follow-up. The volume changes that were determined by perometer and the evaluation of physical disability and disease-specific QoL measures in addition to the assessment of quantitive ultrasonographic changes enrich our results.

In conclusion, adjustable compression velcro-wrap (Circaid Reduction-kit) performed as a part of CDT can greatly reduce the volume similar to short-stretch multilayer bandages, as well as improve the impaired QoL, both in short and long period up to 1 month. We hope that the results of this study will contribute to planning of the lower leg lymphedema treatment in clinical practice and we suggest the use of velcro-adaptive compression devices as a comfortable alternative to the conventional multilayer bandages in the active treatment phase of the CDT.

Footnotes

Author Disclosure Statement

No competing financial interest exists.

Funding Information

All compression materials were supplied by Medi Turkey (Elsa Medical Company). No other financial funding or support was received for this study.

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