Formulated collagen gel accelerates healing rate immediately after application in patients with diabetic neuropathic foot ulcers.

Abstract

We assessed the safety and efficacy of Formulated Collagen Gel (FCG) alone and with Ad5PDGF-B (GAM501) compared with Standard of Care (SOC) in patients with 1.5-10.0 cm(2) chronic diabetic neuropathic foot ulcers that healed <30% during Run-in. Wound size was assessed by planimetry of acetate tracings and photographs in 124 patients. Comparison of data sets revealed that acetate tracings frequently overestimated areas at some sites. For per-protocol analysis, 113 patients qualified using acetate tracings but only 82 qualified using photographs. Prior animal studies suggested that collagen alone would have little effect on healing and would serve as a negative control. Surprisingly trends for increased incidence of complete closure were observed for both GAM501 (41%) and FCG (45%) vs. Standard of Care (31%). By photographic data, Standard of Care had no significant effect on change in wound radius (mm/week) from during Run-in to Week 1 (-0.06 ± 0.32 to 0.78 ± 1.53, p=ns) but both FCG (-0.08 ± 0.61 to 1.97 ± 1.77, p<0.002) and GAM501 (-0.02 ± 0.58 to 1.46 ± 1.37, p<0.002) significantly increased healing rates that gradually declined over subsequent weeks. Both GAM501 and FCG appeared to be safe and well tolerated, and alternate dosing schedules hold promise to improve overall complete wound closure in adequately powered trials.

• Authors: Peter Blume, Vickie R Driver, Arthur J Tallis, Robert S Kirsner, Roy Kroeker, Wyatt G Payne, Soma Wali, William Marston, Cyaandi Dove, Robert L Engler, Lois A Chandler, Barbara K Sosnowski
• Journal: Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society (Wound Repair Regen) 2011 May-Jun Vol. 19 Issue 3 Pg. 302-8 ISSN: 1524-475X [Electronic] United States
• PMID: 21371164 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)
• Copyright: © 2011 by the Wound Healing Society.

Chemical References

• Angiogenesis Inducing Agents
• Gels
• Platelet-Derived Growth Factor
• Proto-Oncogene Proteins c-sis
• Becaplermin
• Collagen

Topics

• Adenoviridae (genetics)
• Angiogenesis Inducing Agents (administration & dosage)
• Becaplermin
• Collagen (administration & dosage, chemical synthesis, pharmacology, therapeutic use)
• Diabetic Foot (physiopathology, therapy)
• Gels
• Genetic Therapy (methods)
• Genetic Vectors (administration & dosage)
• Humans
• Platelet-Derived Growth Factor (administration & dosage)
• Proto-Oncogene Proteins c-sis
• Wound Healing (drug effects, radiation effects)