Use of Integra Dermal Regeneration Template for Limb Salvage in Diabetic Patients With No-Option Critical Limb Ischemia

Abstract

We have analyzed in a retrospective study of consecutive diabetic patients affected by no-option critical limb ischemia (CLI) the efficacy of the dermal substitute Integra Dermal Regeneration Template for treatment of complicated foot lesions. The primary end point was limb salvage and 1-year amputation-free survival. The secondary end point was healing time of surgical site. Between October 2014 and October 2017, 1024 patients with diabetic foot ulcer (DFU) and CLI were admitted. In 84 patients (8.2%), there was a failure in distal revascularization with a persistent CLI after the procedure. Despite the persistent CLI, a group of 26 patients of this cohort obtained complete wound healing. Among them, 13 patients were treated with surgical debridement or open amputations and application of dermal substitute Integra Dermal Regeneration Template and the other 13 patients were treated without any dermal substitute. The Integra group healed within a mean time of 83.5 days, and the control group healed within a mean of 139 days ( P = .028). No major amputation was carried out at 1-year follow-up in the Integra group versus 15% in the control group. A conservative foot surgery or an approach with minor amputation in diabetic patients with no-option CLI may achieve limb salvage. The use of Integra Dermal Regeneration Template in patients with DFU and no-option CLI may be a useful option in a limb salvage program.

Dermal Regeneration Template in the Management and Reconstruction of Burn Injuries and Complex Wounds: A Review

“…Similarly, among 26 diabetic patients who achieved complete wound healing of no-option critical limb ischemia, DRT (n = 13) was associated with faster healing time (84 versus 140 days) and a lack of major amputations (0 versus 15%) compared with a control group (n = 13) not receiving a dermal matrix. 28 …”

“…Similarly, among 26 diabetic patients who achieved complete wound healing of no-option critical limb ischemia, DRT (n = 13) was associated with faster healing time (84 versus 140 days) and a lack of major amputations (0 versus 15%) compared with a control group (n = 13) not receiving a dermal matrix. 28 For patients with DFU, DRT is associated with improved wound closure, a low rate of amputation, and improved quality of life. There are limited data on limb salvage in other patient groups.…”

Therapeutic Alternatives in Diabetic Foot Patients without an Option for Revascularization: A Narrative Review

“…After extensive minor amputations of no-option diabetic patients, major amputation could be avoided by skin replacement material stimulating the synthesis of extracellular matrix from fibroblasts and creating a 'neodermis' [50]. The study included 26 patients.…”

Wound dressings: curbing inflammation in chronic wound healing

“…Integra® Dermal Regeneration Template (Integra Life Sciences Corporation, Plainsboro, New Jersey, US) was the first dermal skin substitute product approved by the US Food and Drug Administration (FDA). It consists of a porous matrix of cross-linked bovine tendon collagen type I, shark chondroitin-6-sulfate GAG and covered by a semi-permeable silicone membrane [47,[49][50][51][52][53]. Chondroitin-6-sulfate GAG has been shown to have antiinflammatory effect on macrophages; however, when the effects of Integra® on macrophage phenotype was analysed, a temporal down-regulation of 'M2a' macrophages (ECM deposition macrophages) was observed [54,55].…”