Failure rates of artificial dermis products in treatment of diabetic foot ulcer: A systematic review and network meta‐analysis

Abstract

Diabetic foot ulcer (DFU) is a frequent complication in diabetic patients, occurring in up to 25% of those affected. Among the treatments available to clinicians, the use of bioengineered skin substitutes is an attractive alternative. Artificial dermis functions as a matrix, covering the wound and supporting healing and reconstruction of the lost tissue. This study was aimed at reviewing the use of five regeneration matrices (namely, Integra, Nevelia, Matriderm, Pelnac, and Renoskin) as reported by clinical trials. We searched Medline, Embase, ISI Web of Science, Scopus, and Cochrane Central Register of Controlled Trials databases for relevant studies. Risk of failure rates was analysed by relative risk ratio method and complete ulcer healing was studied using network meta-analysis. Thirteen studies (12 randomized clinical trials and one cohort study) were eligible for analysis. The network meta-analysis based on a single study for Matriderm and 12 studies for other products showed that Matriderm was statistically inferior in achieving complete ulcer healing, as compared to all other products combined. In the second phase analysis, which was limited to three studies using artificial dermis products, there was a 57% reduction in the risk of reepithelialization failure for DFU patients who used Matriderm or Pelnac, compared to those who used Pelnac with basic fibroblast growth factor spray or skin grafting. The data showed an overall low failure rate suggesting that these bioengineered skin products provide a suitable support and microenvironment for healing of DFUs with low ulcer recurrence rates. This systematic review with meta-analysis highlights the pressing need for more studies investigating the safety, efficacy and failure rates of regeneration matrices in the treatment of DFUs.

Use of Nevelia Dermal-Epidermal Regenerative Template in the Management of Ischemic Diabetic Foot Postsurgical Wounds

“…Recent experiences have shown that DES utilized as therapeutic tools in treating diabetic neuropathic ulcers give very good results, with ulcers size from 2.7 to 9.7 cm 2 , significantly smaller than the wounds treated in our experience. 11,12 Our experience has shown that using the DES in very large postsurgical wounds, even in absence of a subsequent skin graft, has given very good healing rates. In addition to its clinical efficacy, its use might have, in theory, economic advantages such as fast hospital discharge, easy management in an outpatient setting, and elimination of new additional surgical procedures for skin graft.…”

“…Recent evidence supports the use of 2-layer dermal substitutes as single-step treatment in promoting healing of full-thickness noninfected, nonischemic foot ulcers, with sizes ranging from 2.7 to 9.7 cm 2 , in diabetic patients. 11,12 We report the outcomes of consecutive diabetic patients with critical limb ischemia (CLI), treated according to our limb salvage protocol, in which during the reparative time, a bilayer DES was applied to manage a postsurgical extensive tissue loss but without the subsequent skin graft.…”

Design of a Novel Two‐Component Hybrid Dermal Scaffold for the Treatment of Pressure Sores

“…Integra has been used in the treatment of pressure sores with reported wound closure. However, the main disadvantage of using Integra is a risk of infection due to the collection of fluid underneath the silicone layer . Our proposed hybrid scaffold has a punched silicone membrane to allow fluid flow thus potentially eliminating the problems previously reported with Integra.…”

“…However, the main disadvantage of using Integra is a risk of infection due to the collection of fluid underneath the silicone layer. [8,56] Our proposed hybrid scaffold has a punched silicone membrane to allow fluid flow thus potentially eliminating the problems previously reported with Integra. Another disadvantage of using Integra is that it is not easily biodegradable and has been reported to stay in the body for up to two years after implantation, with an associated risk of inflammatory reaction.…”

Vasculogenic Chronic Ulcer: Tissue Regeneration with an Innovative Dermal Substitute

“…They represent a relatively new therapeutic option in chronic wound management [44,45] with a growing evidence base in diabetic and venous ulcers [30,31]. Recently, Tchero et al [46] in a systematic review with meta-analysis on dermal substitute, conclude that the data showed an overall low failure rates suggesting that these bioengineered skin products provide a suitable support and microenvironment for healing of diabetic foot ulcers but that is a pressing need for more studies.…”