Cellular versus acellular matrix devices in the treatment of diabetic foot ulcers: Interim results of a comparative efficacy randomized controlled trial

Catherine N. Tchanque-Fossuo, Sara E. Dahle, Hadar Lev-Tov, Kaitlyn I.M. West, Chin-Shang Li, David M Rocke, Roslyn Rivkah Isseroff

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1 Citation (Scopus)

Abstract

Healing of diabetic foot ulcers is a major challenge. Despite adhering to optimal standard of care (SOC), less than 30% of wounds heal after 20 weeks. Advanced cellular tissue-based products have shown better healing over SOC, albeit with great cost and modest improvement. We hypothesized no difference in healing effected by either cellular (Dermagraft), noncellular (Oasis) devices, relative to SOC in treating diabetic foot ulcer in a randomized controlled trial. The primary and secondary outcomes were the percentage of subjects that achieved complete wound closure by study endpoint (12 weeks of treatment) and study completion, respectively. During the 2-week screening phase with SOC, subjects with 40% change in ulcer size were excluded. After randomization, 56 patients entered an active treatment phase (8 weeks) followed by a maintenance phase (4-week SOC), with endpoint at visit 15, and 4 monthly follow-up visits. There was equal distribution of demographic data (p>.05) and no difference in initial wound characteristics (p>.05) between all groups. No differences were observed in complete wound closure by 12 and 28 weeks of treatment, nor were there any difference in percentage area reduction from treatment weeks 1 to 12 and from treatment weeks 1 to 28 between the groups. Each of the treatment arms showed statistically significant reduction in wound area from treatment weeks 1 to 28 (p<.05). This exploratory analysis suggests that the outcomes of treatment with either Dermagraft or Oasis matrix are comparable. We have completed enrollment, and the final data analysis is underway to make definitive conclusions.

Original languageEnglish (US)
JournalJournal of Tissue Engineering and Regenerative Medicine
DOIs
StatePublished - Jan 1 2019

Fingerprint

Diabetic Foot
Randomized Controlled Trials
Standard of Care
Equipment and Supplies
Wounds and Injuries
Therapeutics
Screening
Random Allocation
Tissue
Ulcer
Maintenance
Demography
Costs and Cost Analysis
Costs

Keywords

  • acellular
  • cellular
  • Dermagraft
  • diabetic foot ulcer
  • neuropathic
  • Oasis

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Biomaterials
  • Biomedical Engineering

Cite this

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title = "Cellular versus acellular matrix devices in the treatment of diabetic foot ulcers: Interim results of a comparative efficacy randomized controlled trial",
abstract = "Healing of diabetic foot ulcers is a major challenge. Despite adhering to optimal standard of care (SOC), less than 30{\%} of wounds heal after 20 weeks. Advanced cellular tissue-based products have shown better healing over SOC, albeit with great cost and modest improvement. We hypothesized no difference in healing effected by either cellular (Dermagraft), noncellular (Oasis) devices, relative to SOC in treating diabetic foot ulcer in a randomized controlled trial. The primary and secondary outcomes were the percentage of subjects that achieved complete wound closure by study endpoint (12 weeks of treatment) and study completion, respectively. During the 2-week screening phase with SOC, subjects with 40{\%} change in ulcer size were excluded. After randomization, 56 patients entered an active treatment phase (8 weeks) followed by a maintenance phase (4-week SOC), with endpoint at visit 15, and 4 monthly follow-up visits. There was equal distribution of demographic data (p>.05) and no difference in initial wound characteristics (p>.05) between all groups. No differences were observed in complete wound closure by 12 and 28 weeks of treatment, nor were there any difference in percentage area reduction from treatment weeks 1 to 12 and from treatment weeks 1 to 28 between the groups. Each of the treatment arms showed statistically significant reduction in wound area from treatment weeks 1 to 28 (p<.05). This exploratory analysis suggests that the outcomes of treatment with either Dermagraft or Oasis matrix are comparable. We have completed enrollment, and the final data analysis is underway to make definitive conclusions.",
keywords = "acellular, cellular, Dermagraft, diabetic foot ulcer, neuropathic, Oasis",
author = "Tchanque-Fossuo, {Catherine N.} and Dahle, {Sara E.} and Hadar Lev-Tov and West, {Kaitlyn I.M.} and Chin-Shang Li and Rocke, {David M} and Isseroff, {Roslyn Rivkah}",
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AU - Tchanque-Fossuo, Catherine N.

AU - Dahle, Sara E.

AU - Lev-Tov, Hadar

AU - West, Kaitlyn I.M.

AU - Li, Chin-Shang

AU - Rocke, David M

AU - Isseroff, Roslyn Rivkah

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