Use of Amnion Transfer in Resistant Nonhealing Venous Leg Ulcers

Abstract

In the treatment of venous leg ulcers, after adopting many treatment modalities, at times we are still left with a local indolent problem, "the resistant nonhealing venous ulcer." With repeated surgical procedures failing to obtain a healed ulcer, constant pain, persistent discharging wound, infections, etc., many a patient turn hostile. Also, there comes a dimension of despair in the health feeling of the patient. This prospective study was conducted in 40 patients, who were within the inclusion criteria (January 2006-January 2010, 12 males and 28 females, mean age 45 years). A single amniotic membrane (AM) transfer was done after preparation of the wound, and the parameters were assessed periodically. Follow-up for a minimum period of 1 year in all cases and a maximum period of 3 years in many cases (38) was done. Significant clinical response was defined as an ulcer healing greater than 75 % of the original area. Treatment failure was taken as a persistence or recurrence of more than 25 % of the ulcer area in a 1-year follow-up period. The preliminary results of good ulcer healing and no recurrence are encouraging, even up to 3-year follow-up. This proof-of-concept study demonstrates that AM transfer is useful, safe, inexpensive, readily available, and well accepted by patients, with tremendous potential in promoting epithelial healing in "the resistant nonhealing chronic venous leg ulcer."

A systematic review on clinical outcomes of human amniotic membrane preparations in the management of venous leg ulcers

“…In one RCT [17] a notable reduction in the baseline surface area of the ulcers in patients treated with HAM was observed. A prospective study conducted by Francis et al [19] demonstrated less than a 30% of recurrence rate of venous leg ulcers during a 3-year followup period. Furthermore, Hanumanthappa et al [20] in their prospective comparative study have shown that 80% of ulcers achieved epithelialization at 3 weeks with HAM dressing and it was statistically significant.…”

“…We found 3 randomized control trials [16,17,18] and all were multicenter trials conducted in the United States. Out of 4 prospective studies, 2 were done in India [19,20] and one each in France [21] and Spain [22].…”

“…Except study done by Francis et al, in other studies, an adjunct compressive bandage has been used. Long-term recurrence after therapy had been assessed in only one study (less than 30% in 3 years) [19]. Previous epidemiological studies imply the recurrence rate is 26-70% [23].…”

“…Therefore, the effect of superficial venous surgery on ulcer healing cannot be disregarded in the current study. Most of the studies included in this review have been done before 2018 and only one study mentioned that the patients in their study had undergone surgery for varicose veins before the treatment with amniotic membrane allografts [19]. Two studies [20,21] mentioned that the patients in the study had not received surgical treatment for varicose veins.…”

Application of Amniotic Membrane Allografts in Advanced Venous Leg Ulcer: A Case Study and Literature Review

“…At week 16, the mean VLU area was reduced by 72% for allograft-treated wounds compared to 39% with standard of care. In a 2013 prospective study, 40 patients with non healing venous ulcers were observed for one to three years following an amniotic membrane (AM) transfer 19 . The inclusion criteria for this study included; patients between 40-50 years of age, non healing venous leg ulcers 3cm in size or greater, ulcer duration greater than 3-months despite surgery or split skin graft.…”