Randomized prospective double-blind trial in healing chronic diabetic foot ulcers. CT-102 activated platelet supernatant, topical versus placebo.

Abstract

OBJECTIVE:

To assess the efficacy of topically applied CT-102 APST for treating diabetic neurotrophic foot ulcers.

RESEARCH DESIGN AND METHODS:

Thirteen patients entered a randomized, double-blind trial of topically applied CT-102 APST vs. placebo (normal saline) gauze dressings for the treatment of nonhealing diabetic neurotrophic foot ulcers. CT-102 APST (Curative Technologies, Setauket, NY) was prepared from homologous platelets and contained multiple growth factors including PDGF, PDAF, EGF, PF-4, TGF-beta, aFGF, and bFGF. Inclusion criteria for subjects included diabetes, ulcer of > 8 wk duration, peri-wound transcutaneous oxygen tension > 30 mmHg, platelet count > 100,000/mm3, and no wound infection. Wounds were excised before entry and were > 700 mm3 but < 50,000 mm3 in volume, < 100 cm2 in area, and involved subcutaneous tissue.

RESULTS:

In the CT-102 group, 5 of 7 ulcers were healed (100% epithelialized) by 15 wk, but only 1 of 6 ulcers was healed by 20 wk with placebo (P < 0.05). Average percent reduction in ulcer area at 20 wk was 94% for CT-102 vs. 73% for placebo. Daily reduction in ulcer volume was 73.8 +/- 42.4 mm3/day (mean +/- SE) for CT-102 vs. 21.8 +/- 8.1 mm3/day for placebo (P < 0.05). Daily reduction in ulcer area was 6.2 +/- 1.8 mm2/day for CT-102 vs. 1.8 +/- 0.4 mm2/day for placebo (P < 0.05).

CONCLUSIONS:

CT-102 significantly accelerated wound closure in diabetic leg ulcers when administered as part of a comprehensive program for the healing of chronic ulcers.

• Authors: D L Steed, J B Goslen, G A Holloway, J M Malone, T J Bunt, M W Webster
• Journal: Diabetes care (Diabetes Care) Vol. 15 Issue 11 Pg. 1598-604 (Nov 1992) ISSN: 0149-5992 [Print] United States
• PMID: 1468291 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• CT-102 activated platelet supernatant
• Complex Mixtures
• Growth Substances
• Placebos

Topics

• Chronic Disease
• Complex Mixtures
• Diabetes Complications
• Diabetes Mellitus (physiopathology)
• Double-Blind Method
• Female
• Foot Ulcer (drug therapy, physiopathology)
• Growth Substances (therapeutic use)
• Humans
• Male
• Middle Aged
• Placebos
• Platelet Activation
• Prospective Studies
• Time Factors
• Wound Healing