Graftskin, a Human Skin Equivalent, Is Effective in the Management of Noninfected Neuropathic Diabetic Foot Ulcers

Abstract

OBJECTIVE— We assessed in a randomized prospective trial the effectiveness of Graftskin, a living skin equivalent, in treating noninfected nonischemic chronic plantar diabetic foot ulcers. RESEARCH DESIGN AND METHODS— In 24 centers in the U.S., 208 patients were randomly assigned to ulcer treatment either with Graftskin (112 patients) or saline-moistened gauze (96 patients, control group). Standard state-of-the-art adjunctive therapy, which included extensive surgical debridement and adequate foot off-loading, was provided in both groups. Graftskin was applied at the beginning of the study and weekly thereafter for a maximum of 4 weeks (maximum of five applications) or earlier if complete healing occurred. The major outcome of complete wound healing was assessed by intention to treat at the 12-week follow-up visit. RESULTS— At the 12-week follow-up visit, 63 (56%)Graftskin-treated patients achieved complete wound healing compared with 36(38%) in the control group (P = 0.0042). The Kaplan-Meier median time to complete closure was 65 days for Graftskin, significantly lower than the 90 days observed in the control group (P = 0.0026). The odds ratio for complete healing for a Graftskin-treated ulcer compared with a control-treated ulcer was 2.14 (95% CI 1.23-3.74). The rate of adverse reactions was similar between the two groups with the exception of osteomyelitis and lower-limb amputations, both of which were less frequent in the Graftskin group. CONCLUSIONS— Application of Graftskin for a maximum of 4 weeks results in a higher healing rate when compared with state-of-the-art currently available treatment and is not associated with any significant side effects. Graftskin may be a very useful adjunct for the management of diabetic foot ulcers that are resistant to the currently available standard of care.

Diagnosis and Treatment of Diabetic Foot Infections

“…Investigators and industry representatives have advocated many types of wound-care treatments, including wound vacuum-drainage systems [203][204][205][206], recombinant growth factors [207][208][209][210][211][212], skin substitutes [203,[213][214][215][216], antimicrobial dressings [217][218][219], and maggot (sterile larvae) therapy [220][221][222]. Although each treatment likely has some appropriate indications, for infected wounds, available evidence is insufficient to recommend routine use of any of these modalities for treatment or prophylaxis.…”

Collect Data, Tell Stories: Utilizing Available Data to Improve Wound Product Selection, Reduce Costs, and Improve Outcomes

“…Data for the percentage of ulcers healed over a period of 12 weeks were obtained from pivotal randomized clinical trials found in the literature. [4][5][6][7][8][9] When the cost for 12 weeks of treatment is divided by the percentage of patients healed in 12 weeks, this gives a cost per 1% patients healed. Using Apligraf as an example in the context of a venous leg ulcer and four applications over 12 weeks, cost for duration of care is $6,816 as determined in first-level calculations.…”

Comparison of advanced therapy medicinal product gingiva and skin substitutes and their in vitro wound healing potentials

“…For skin, several autologous and allogeneic dermal and bi‐layered (epidermis and dermis) constructs have been described over the past years to heal venous and arterial leg ulcers, diabetic foot ulcers and pressure ulcers (Falanga & Sabolinski, 1999; Jones, Nelson, & Al‐Hity, 2013; Kirsner et al, 2012; Marston, Hanft, Norwood, & Pollak, 2003; Veves, Falanga, Armstrong, & Sabolinski, 2001; Wu, Marston, & Armstrong, 2010; Zaulyanov & Kirsner, 2007). Also, application of autologous epidermal cells has been described for treating large burn wounds (Gardien et al, 2016; Gravante et al, 2007; Wood et al, 2012).…”