NorLeu3-A(1-7) stimulation of diabetic foot ulcer healing: Results of a randomized, parallel-group, double-blind, placebo-controlled phase 2 clinical trial

Peter P. Balingit, David G. Armstrong, Alexander M. Reyzelman, Laura Bolton, Shelagh J. Verco, Kathleen E. Rodgers, Katherine A. Nigh, Gere S. DiZerega

Research output: Contribution to journalArticle

29 Scopus citations

Abstract

This randomized, double-blind, placebo-controlled Phase 2 clinical trial explored NorLeu3-A(1-7) (DSC127) safety and healing efficacy in diabetic foot ulcers. Patients with chronic, noninfected, neuropathic, or neuroischemic plantar Wagner Grade 1 or 2 foot ulcers (n = 172) were screened for nonhealing. Subjects were randomized to receive 4 weeks' once-daily topical treatment with 0.03% DSC127 (n = 26), 0.01% DSC127 (n = 27), or Placebo (n = 24), followed by 20 weeks' standard of care. DSC127 was assessed for safety (including laboratory values and adverse events), primary efficacy (% ulcers completely epithelialized at Week 12), and durability of effect. Baseline, demography, and safety parameters were compared between intent-to-treat groups and were comparable. Dose-response curves for DSC127 effect on % area reduction from baseline at Week 12 (40% placebo; 67% 0.01% DSC127; 80% 0.03% DSC127) and 24 (23% placebo; 53% 0.01% DSC127; 95% 0.03% DSC127) followed a log-linear pattern for both intent-to-treat and per-protocol populations. Covariate analysis compared reduction in ulcer area, depth, and volume from baseline; reductions in the 0.03% DSC127 group were greater at Weeks 12 and 24. Placebo-treated ulcers healed in a median 22 weeks vs. 8.5 weeks for 0.03%DSC127 (p = 0.04). This study provides preliminary evidence that DSC127 is safe and effective in accelerating the healing of diabetic foot ulcers.

Original languageEnglish (US)
Pages (from-to)482-490
Number of pages9
JournalWound Repair and Regeneration
Volume20
Issue number4
DOIs
StatePublished - 2012

ASJC Scopus subject areas

  • Surgery
  • Dermatology

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