A clinical trial of Integra Template for diabetic foot ulcer treatment

Vickie R. Driver, Lawrence A. Lavery, Alexander M. Reyzelman, Timothy G. Dutra, Cyaandi R. Dove, Sandra V. Kotsis, Hyungjin Myra Kim, Kevin C. Chung

Research output: Contribution to journalArticle

49 Citations (Scopus)

Abstract

Individuals with diabetes mellitus are at an increased risk of developing a diabetic foot ulcer (DFU). This study evaluated the safety and efficacy of Integra Dermal Regeneration Template (IDRT) for the treatment of nonhealing DFUs. The Foot Ulcer New Dermal Replacement Study was a multicenter, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption. Thirty-two sites enrolled and randomized 307 subjects with at least one DFU. Consented patients were entered into the 14-day run-in phase where they were treated with the standard of care (0.9% sodium chloride gel) plus a secondary dressing and an offloading/protective device. Patients with less than 30% reepithelialization of the study ulcer after the run-in phase were randomized into the treatment phase. The subjects were randomized to the control treatment group (0.9% sodium chloride gel; n = 153) or the active treatment group (IDRT, n = 154). The treatment phase was 16 weeks or until confirmation of complete wound closure (100% reepithelialization of the wound surface), whichever occurred first. Following the treatment phase, all subjects were followed for 12 weeks. Complete DFU closure during the treatment phase was significantly greater with IDRT treatment (51%) than control treatment (32%; p = 0.001) at sixteen weeks. The median time to complete DFU closure was 43 days for IDRT subjects and 78 days for control subjects in wounds that healed. The rate of wound size reduction was 7.2% per week for IDRT subjects vs. 4.8% per week for control subjects (p = 0.012). For the treatment of chronic DFUs, IDRT treatment decreased the time to complete wound closure, increased the rate of wound closure, improved components of quality of life and had less adverse events compared with the standard of care treatment. IDRT could greatly enhance the treatment of nonhealing DFUs.

Original languageEnglish (US)
Pages (from-to)891-900
Number of pages10
JournalWound Repair and Regeneration
Volume23
Issue number6
DOIs
StatePublished - Nov 1 2015

Fingerprint

Diabetic Foot
Clinical Trials
Regeneration
Skin
Therapeutics
Wounds and Injuries
Standard of Care
Sodium Chloride
Gels
Protective Devices
Foot Ulcer
Bandages
Ulcer
Diabetes Mellitus

ASJC Scopus subject areas

  • Dermatology
  • Surgery

Cite this

Driver, V. R., Lavery, L. A., Reyzelman, A. M., Dutra, T. G., Dove, C. R., Kotsis, S. V., ... Chung, K. C. (2015). A clinical trial of Integra Template for diabetic foot ulcer treatment. Wound Repair and Regeneration, 23(6), 891-900. https://doi.org/10.1111/wrr.12357

A clinical trial of Integra Template for diabetic foot ulcer treatment. / Driver, Vickie R.; Lavery, Lawrence A.; Reyzelman, Alexander M.; Dutra, Timothy G.; Dove, Cyaandi R.; Kotsis, Sandra V.; Kim, Hyungjin Myra; Chung, Kevin C.

In: Wound Repair and Regeneration, Vol. 23, No. 6, 01.11.2015, p. 891-900.

Research output: Contribution to journalArticle

Driver, VR, Lavery, LA, Reyzelman, AM, Dutra, TG, Dove, CR, Kotsis, SV, Kim, HM & Chung, KC 2015, 'A clinical trial of Integra Template for diabetic foot ulcer treatment', Wound Repair and Regeneration, vol. 23, no. 6, pp. 891-900. https://doi.org/10.1111/wrr.12357
Driver, Vickie R. ; Lavery, Lawrence A. ; Reyzelman, Alexander M. ; Dutra, Timothy G. ; Dove, Cyaandi R. ; Kotsis, Sandra V. ; Kim, Hyungjin Myra ; Chung, Kevin C. / A clinical trial of Integra Template for diabetic foot ulcer treatment. In: Wound Repair and Regeneration. 2015 ; Vol. 23, No. 6. pp. 891-900.
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abstract = "Individuals with diabetes mellitus are at an increased risk of developing a diabetic foot ulcer (DFU). This study evaluated the safety and efficacy of Integra Dermal Regeneration Template (IDRT) for the treatment of nonhealing DFUs. The Foot Ulcer New Dermal Replacement Study was a multicenter, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption. Thirty-two sites enrolled and randomized 307 subjects with at least one DFU. Consented patients were entered into the 14-day run-in phase where they were treated with the standard of care (0.9{\%} sodium chloride gel) plus a secondary dressing and an offloading/protective device. Patients with less than 30{\%} reepithelialization of the study ulcer after the run-in phase were randomized into the treatment phase. The subjects were randomized to the control treatment group (0.9{\%} sodium chloride gel; n = 153) or the active treatment group (IDRT, n = 154). The treatment phase was 16 weeks or until confirmation of complete wound closure (100{\%} reepithelialization of the wound surface), whichever occurred first. Following the treatment phase, all subjects were followed for 12 weeks. Complete DFU closure during the treatment phase was significantly greater with IDRT treatment (51{\%}) than control treatment (32{\%}; p = 0.001) at sixteen weeks. The median time to complete DFU closure was 43 days for IDRT subjects and 78 days for control subjects in wounds that healed. The rate of wound size reduction was 7.2{\%} per week for IDRT subjects vs. 4.8{\%} per week for control subjects (p = 0.012). For the treatment of chronic DFUs, IDRT treatment decreased the time to complete wound closure, increased the rate of wound closure, improved components of quality of life and had less adverse events compared with the standard of care treatment. IDRT could greatly enhance the treatment of nonhealing DFUs.",
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