SLR - January 2023 - Tehreem Sajjad, PGY-3 DPM
Title: A Multicenter, Randomized, Controlled, Clinical Trial Evaluating Dehydrated Human Amniotic Membrane in the Treatment of Venous Leg UlcersReference: Serena TE, Orgill DP, Armstrong DG, Galiano RD, Glat PM, Carter MJ, Kaufman JP, Li WW, Zelen CM. A Multicenter, Randomized, Controlled, Clinical Trial Evaluating Dehydrated Human Amniotic Membrane in the Treatment of Venous Leg Ulcers. Plast Reconstr Surg. 2022 Nov 1;150(5):1128-1136. doi: 10.1097/PRS.0000000000009650. Epub 2022 Sep 2. PMID: 36067479; PMCID: PMC9586828.
Level of Evidence: One
Reviewed By: Tehreem Sajjad, PGY-3 DPM
Residency Program: Beaumont Hospital, Farmington Hills, MI
Podiatric Relevance: One of the most common pathologies podiatric physicians encounter on a routine basis are venous stasis ulcerations. While lower extremity venous ulcerations have a wide variety of etiologies, the most common cause is chronic venous insufficiency (CVI). Patients with CVI have impaired venous return, leading to persistent venous hypertension and chronic edema, eczema, recurring ulcerations, and lipodermatosclerosis. The standard of care for venous stasis ulcerations is compression. However, as shown by previous research, this is not sufficient. This study evaluates the effectiveness of dehydrated human amnion and chorion allograft (dHACA) in addition to the standard of care compared to standard of care alone in an attempt to effectively heal and decrease venous stasis ulcerations.
Methods: This multi-center prospective randomized controlled trial took place from November 2015 to January 2019 and included 60 total patients (20 in the control group and 40 in the treatment group). dHACA is an aseptically processed amnion and chorion donated human tissue and retains the structural properties of the extracellular matrix. All patients were screened for eligibility based on inclusion and exclusion criteria. If considered an appropriate candidate, patients were divided into one of three groups: standard of care alone (control), weekly dHACA application with standard of care, or biweekly dHACA application plus standard of care. Patients were then randomly placed in a study group and for the next 12 weeks, a study investigator applied dHACA either weekly or biweekly or not at all. Ulcerations were digitally photographs and measured before and after weekly debridement.
Results: To test for statistical differences between study groups, chi-square or Fisher exact tests were performed for categorical variables and one-way analysis of variance were performed for continuous variables. At 12 weeks, a significantly greater number of venous leg ulcers had healed in the two groups treated with dHACA (weekly or biweekly applications) compared to the control group. While only 6 ulcerations healed in the control group at the 12 week mark, the biweekly dHACA group had 15 healed ulcerations. At 12 weeks, the control group had a median percentage area reduction of 75% while the dHACA groups had a significantly higher median of 100%
Conclusion: The evaluation and treatment of venous stasis ulcerations reportedly costs billions annually. This study demonstrated the successful implementation of a dehydrated amniotic allograft, regardless of frequency, as a supplement to the standard of care in treating chronic venous stasis ulcerations and shows that dHACA should be considered an adjunct to standard of care for chronic, recurring venous ulcerations.