Practice patterns of adjunctive therapy for venous leg ulcers

Abstract

Objectives

Venous leg ulcers (VLU) are the most severe clinical sequelae of venous reflux and post thrombotic syndrome. There is a consensus that ablation of refluxing vein segments and treatment of significant venous obstruction can heal VLUs. However, there is wide disparity in the use and choice of adjunctive therapies for VLUs. The purpose of this study was to assess these practice patterns among members of the American Venous Forum.

Methods

The AVF Research Committee conducted an online survey of its own members, which consisted of 16 questions designed to determine the specialty of physicians, location of treatment, treatment practices and reimbursement for treatment of VLUs

Results

The survey was distributed to 667 practitioners and a response rate of 18.6% was achieved. A majority of respondents (49.5%) were vascular specialists and the remaining were podiatrists, dermatologists, primary care doctors and others. It was found that 85.5% were from within the USA, while physicians from 14 other countries also responded. Most of the physicians (45%) provided adjunctive therapy at a private office setting and 58% treated less than 5 VLU patients per week. All respondents used some form of compression therapy as the primary mode of treatment for VLU. Multilayer compression therapy was the most common form of adjunctive therapy used (58.8%) and over 90% of physicians started additional modalities (biologics, negative pressure, hyperbaric oxygen and others) when VLUs failed compression therapy, with a majority (65%) waiting less than three months to start them. Medicare was the most common source of reimbursement (52.4%).

Conclusions

Physicians from multiple specialties treat VLU. While most physicians use compression therapy, there is wide variation in the selection and point of initiation for additional therapies once compression fails. There is a need for high-quality data to help establish guidelines for adjunctive treatment of VLUs and to disseminate them to physicians across multiple specialties to ensure standardized high-quality treatment of patients with VLUs.

Keywords

Wound care venous ulceration venous stasis

Introduction

Venous leg ulcers (VLU) are a large source of morbidity, create a large socioeconomic burden, and adversely impact quality of life.^1–3 Over 2.7 million Americans are affected by chronic venous insufficiency manifesting as leg edema, lipodermatosclerosis and VLU.⁴ Many patients with VLU have superficial and deep venous reflux with the majority having primary venous disease. In addition, about one-third of these ulcers are related to long-term sequelae of post thrombotic syndrome.⁵ The great saphenous vein is preferentially affected in the majority of patients presenting with active or with healed VLU. Various case series and small-randomized controlled trials have demonstrated that both ligation and stripping and endovenous ablation of the culprit refluxing great or short saphenous vein can diminish time to heal VLU.^1,6 It may take 6 to 12 months for a venous ulcer to heal completely and the recurrence rates can be as high as 70% within five years of complete closure.⁷ Venous reflux disease in great sephanous vein may be treated with vein stripping or endovenous ablation. In addition to surgical treatments of the venous reflux, several adjunct therapies are available to treat venous ulcers. While these have been reported to be efficacious, there is a lack of consensus and evidence-based data on the timing or choice of such therapies.⁸ Treatment of venous ulcers likely costs more than three billion dollars per year.^9,10 The research committee of the American Venous Forum (AVF) conducted a survey of its membership to assess trends in the use of adjunct therapy for treatment of VLU with a focus on the frequency, type and rationale for use of these measures, as well as perceived barriers to their use.

Methods

The AVF research committee designed a questionnaire to better understand treatment patterns for VLU across the USA. The survey consisted of several questions accompanied by a series of pre-specified answers (Table 1). The questionnaire was electronically distributed to the entire membership of the AVF via Survey Monkey (Survey Monkey Inc., Palo Alto, CA, USA). A survey monkey link was mailed to every member of the AVF. The first communication was sent in July 2012. In September 2012, two reminders, one week apart, were sent to the AVF membership. Contributions were voluntary and anonymous. No physician, hospital or patient identifiers were collected.

Table 1.

Questionnaire on practice patterns for venous leg ulcers.

1. In your facility, who cares for patients with venous leg ulcers (VLU)?

a. Vascular specialist

b. Dermatologist

c. Podiatrists

d. Primary care

e. Other (please specify)

2. Where is the care being provided?

a. Dedicated wound care center

b. Private practice/office setting

c. Academic hospital setting

d. Government institution

e. Other (please specify)

3. The number of patients you personally see with active VLU per week?

a. Less than 5

b. 5–10

c. 11–20

d. Over 20

4. Do you have adjunctive therapies in VLU that fail to heal with compression therapy?

a. Yes

b. No

5. If the answer to above question is no, why do you not consider adjunctive therapies?

a. Lack of supporting data

b. Unfamiliarity with the products

c. Cost

d. Reimbursement

e. Inability to easily obtain product

f. Other (please specify)

6. At what time do you consider adjunct wound care (not considering topical therapy) in addition to standard compression therapy?

a. Less than three months

b. 3–4 months

c. 4–6 months

d. Over six months

7. Do you use human skin substitutes (Apligraf, Dermagraft)?

a. Yes

b. No

8. Do you use extracellular matrix biologics (SIS -Small Intestine Submucosa Oasis)?

a. Yes

b. No

9. Do you use negative pressure wound therapy?

a. Yes

b. No

10. Do you use hyperbaric wound therapy?

a. Yes

b. No

11. Do you use multi-chamber compression pumps?

a. Yes

b. No

12. Do you use split thickness skin grafts?

a. Yes

b. No

13. In a wound that responds to therapy, what determines when you discontinue the adjunctive wound modalities?

a. At 50% wound closure

b. Complete wound closure

c. After three months therapy

d. After six months therapy

14. In a wound that fails to respond to therapy, what determines when you discontinue the adjunctive wound modalities?

a. At 50% wound closure

b. Complete wound closure

c. After three months therapy

d. After six months therapy

15. What is your primary mode of compression in treating active VLU?

a. Compression bandaging with multilayers

b. Short stretch bandaging

c. Compression stockings

d. Inelastic compression garments

16. What is your primary mode of reimbursement for services?

a. Medicare

b. Medicaid

c. HMO

d. Private Insurance

The first two questions were designed to determine the specialty and setting of physicians taking care of VLUs. The third question was meant to determine the volume of VLU treated per week. Questions 4–16 were focused on obtaining information about treatment practices for specialists treating VLUs. The last question aimed at gathering data about reimbursement for services provided. The data were collated and analyzed based on physicians or proportion of responses as appropriate.

Results

Demographics of respondents

The survey was distributed to a total of 667 practitioners. A total of 124 members responded, with a response rate of 18.6%. A large proportion of the physicians involved in treating VLUs identified themselves as vascular specialists (49.5%). Vascular specialists were defined as physicians who were trained as vascular surgeons, vascular medicine physicians, cardiologists or phlebologists. Additional respondents included podiatrists (11.3%), dermatologists (9.4%), primary care physicians (11.3%) and other physicians (18.4%; including general surgeons, interventional radiologists and wound care specialists). A majority of the respondents (106) were from 49 states within the USA. International survey responders included three from Argentina, two from Italy, two from Sweden and one each from Austria, Brazil, Curacao, Israel, Japan, Russia, Serbia, South Korea, Switzerland, Turkey, and the UK.

Demographics of VLU care

The majority (n = 56, 45.2%) of VLU treatment was delivered by respondents in a private practice setting in an office, while dedicated wound care centers (n = 31, 24.9%) and academic centers (n = 28, 22.5%) contributed the bulk of remaining care. A majority of respondents saw less than five patients per week and only 6.5% saw more than 20 patients per week (Figure 1).

Figure 1.

Total number of patients with venous leg ulcers treated by respondents per week.

Specifics of VLU treatment modalities

All respondents used some form of compression therapy as the primary mode of treatment for VLU. A majority (58.8%) of respondents used multilayer compression bandaging as their primary mode of compression, while 14.5% used short stretch bandages, 14.5% used elastic compression stockings, and 8.1% used inelastic compression garments (Figure 2).

Figure 2.

Type of compression system utilized for treatment of venous leg ulcers.

Over 90% of physicians utilized additional adjunctive therapies for patients that failed to heal their ulcers with compression. Of these, a majority (65.3%) considered initiating adjunctive wound therapy within three months (Figure 3). Additional questions focused on each major category of adjunctive wound therapy options. We found that 71 (58.7%) used human skin substitutes, 42 (34.7%) used extracellular matrix biologics, 74 (60.7%) used negative pressure wound therapy, 39 (32.2%) used hyperbaric wound therapy, 59 (48%) used multi-chamber compression pumps, and 66 (54.5%) used split thickness skin grafts (Table 2). A majority of physicians used two or more approaches simultaneously to achieve wound closure. When asked about the criteria they used to determine when to discontinue adjunctive wound care modalities for wounds that responded to therapy, 76.6% continued till the wound healed completely and 14.5% discontinued therapy once half the wound was closed, and none would wait beyond 6 months (Table 3). For criteria used to discontinue adjunctive therapy in wounds that failed to heal, 28.2% of respondents used less than 50% wound-closure as the criterion, while most others used duration of therapy 3–6 or >6 months as a way to determine when to stop treatment (Table 3). Also, 28% would continue to use adjunctive wound care beyond six months despite a wound failing to heal to try and still achieve complete wound closure.

Figure 3.

Time to consider initiating adjunct wound care therapy in addition to standard compression therapy.

Table 2.

Adjunctive therapies utilized in VLU patients that fail to heal with compression therapy.

Description	Number answering yes/ Total number of respondents	Percentage
Respondents that use adjunctive therapy	114/123	91.9
Human Skin Substitutes	71/121	58.7
Extracellular Matrix Biologics (SIS Oasis)	42/121	34.7
Negative pressure wound therapy	74/122	60.7
Hyperbaric wound therapy	39/121	32.2
Multi Chamber compression therapy	59/123	48.0
Split thickness skin graft	66/121	54.5

Total number exceeds 100% since each modality is separately queried for each respondent.

Table 3.

Criteria for discontinuing adjunctive wound care therapy.

	Number	Percentage
For wounds that respond to therapy
At 50% wound closure	18	14.5
Complete wound closure	95	76.6
After three months of therapy	2	1.6
After six months of therapy	0	0
Missing value	9	7.3
Total	115	100
For wounds that fail therapy
When < 50% wound closure	35	28.2
Complete wound closure	35	28.2
After three months of therapy	15	12.1
After six months of therapy	27	21.8
Missing value	12	9.7
Total	124	100

Only a small minority of physicians (8.1%) reported not using adjunctive measures to treat VLUs. When queried about the reason for not considering adjunctive therapies in a particular patient, common reasons included lack of supporting data, re-imbursement concerns, and inability to obtain the product. Of all the respondents, 3.2% of physicians quoted unfamiliarity with the products and their cost as the factors responsible for their decision not to consider adjunctive therapies (Table 4). The primary source of reimbursement for care was predominantly Medicare in 52.4% of respondents; private insurers contributed in 32.3% of respondents; while Medicaid (5.6%) and HMOs (4.8%) contributed in smaller proportions of patients.

Table 4.

Reasons for not considering adjunctive therapies.

Reasons	Number	Percentage
Lack of supporting data	3	2.4
Unfamiliarity with the products	2	1.6
Cost	2	1.6
Reimbursement	3	2.4
Inability to easily obtain product	3	2.4
Other	8	6.5
No response	111	89.5
Total	124

Discussion

Our survey demonstrated that physicians from a wide variety of backgrounds treat VLU. A majority of the physicians treating VLU identified themselves as vascular specialists. Most VLUs were treated outside of a wound care center, and favored private or academic office-based practices. The mainstay of treatment was compression. However, failure to heal in three months generally resulted in the addition of adjunctive measures. The most commonly applied measure was tissue-engineered skin substitutes.

The distribution of physicians treating VLU, vascular specialists (vascular surgeons, vascular medicine physicians, cardiologists and phlebologists) as well as primary care physicians, podiatrists, dermatologists, and internists is also reflective of the distribution of specialties represented among the membership of the AVF. The multitude of different specialists caring for VLU underscores the importance of disseminating literature and guidelines pertaining to VLU treatment to include these specialties that treat a significant number of patients. It also explains the relatively wide variety of choices of adjunctive therapies utilized for treating VLU.

Almost half of the respondents treated VLUs in a private practice or academic outpatient office setting and only one-fourth of the ulcers were treated at dedicated wound care centers. This explains the relatively low numbers of VLU patients seen per week (n = 5 per week) amongst our respondents, with only 6.5% of the physicians treating of more than 20 VLU patients per week. These large variations likely reflect the type of practice of the provider, the number of referrals, the amount of clinic time that was spent seeing outpatients, and the experience of the provider.

Historically, VLUs were treated with bed rest and leg elevation. Partsch, Stemmer and others^11–13 highlighted the principles of leg compression and active ambulation as cornerstones for treatment. The Cochrane Collaboration¹⁴ reviewed 39 randomized trials to confirm that compression improved healing rates. These findings appear to have been translated into clinical practice effectively since all respondents utilized some form of compression as the primary mode of treatment. When compared to a single-layer compression system, a four-layer compression system improves ulcer healing times, reduces complications and improves quality of life.¹⁴ Most of our respondents also preferred a multilayer compression bandage. However, as many as 63% of patients may be non-compliant,^15,16 resulting ulcer recurrence rates as high as 89% in five years.¹⁷ Our survey showed that over 90% of physicians would consider adjunctive therapeutic options for patients who failed compression. Most common reasons cited for not considering adjunctive therapies included lack of supporting data, reimbursement issues and inability to obtain the products. This indicates that there remains a knowledge gap among practitioners treating VLU. In addition to setting guidelines, an important goal for relevant societies must include the dissemination of knowledge to a larger audience.

In the recently published SVS/AVF Joint Clinical Practice VLU Guidelines,¹ an important recommendation is the utilization adjuvant therapies after a minimum of 4–6 weeks in VLU that fail to respond to standard wound therapy. Our survey results indicate that nearly two-thirds of practitioners consider adjuvant wound care within three months in VLU that are not responding, and is in line with the SVS/AVF recommendations. However, nearly 61% of practitioners treating VLU utilize negative pressure wound therapy, even though there is insufficient data to demonstrate a clear benefit from this modality for VLU and is not recommended.¹

Topical dressings used for the treatment of venous ulcers include hydrocolloids, foams, alginates, and low-adherent dressings. There is no available scientific evidence to preferentially support any one of these dressings over the other.¹⁸ The modest data available appear to suggest that tissue-engineered skin substitutes used in combination with compression therapy may achieve improved healing rates at six months of follow-up.¹⁹ However, many other varieties of skin substitutes and grafts have been used in the treatment of VLU. These include pinch skin homografts, split-thickness skin homografts, full-thickness skin homografts, xenografts and artificial skin grafts, which include biologic and artificial skin substitutes. Our survey found that human skin substitutes, negative pressure wound therapy, and split thickness skin grafts were very commonly used by physicians, while extracellular matrix biologics, hyperbaric treatment, and multi chamber compression pumps were also popular. About 32% of respondents used hyperbaric wound therapy as an adjunct to treating VLU. The data to support such therapy is lacking, and recommendations favor against utilization of hyperbaric therapy for VLU.¹

In conclusion, this survey indicates that physicians from several specialties are involved in the treatment of VLU and there is wide variation in the practice patterns for the selection of adjunctive therapy once compression treatment fails. The recently published Guidelines by the AVF and Society for Vascular Surgery¹ provide guidance in the diagnosis and treatment for VLU. It is imperative that information from such guidelines be proactively disseminated.

More comparative effectiveness and efficacy trials are necessary to help develop high-quality data that will assist in some of the decision-making that is currently empirical and subjective. This will achieve the goal of effective therapy being applied with the best cost to benefit outcome, and to achieve optimal ulcer healing with reduced recurrences and improved quality of life.

Footnotes

Acknowledgement

The authors thank Kirsten Joranlien and Mary D Dean from AVF administrative team for circulating this survey.

Declaration of Conflicting Interests

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr. Diaz wants to disclose that he is a member of the American Venous Forum Board of Directors.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

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