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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.

SUBMITTER: Blume P

PROVIDER: S-EPMC3443373 | biostudies-literature | 2011 May-Jun

REPOSITORIES: biostudies-literature

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

Blume Peter P Driver Vickie R VR Tallis Arthur J AJ Kirsner Robert S RS Kroeker Roy R Payne Wyatt G WG Wali Soma S Marston William W Dove Cyaandi C Engler Robert L RL Chandler Lois A LA Sosnowski Barbara K BK

Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society 20110303 3

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 ...[more]

PMID: 21371164

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Project description:INTRODUCTION:One in four diabetes patients will develop a foot ulcer over their lifetime. The role of glycaemic control in the healing of foot ulcers in diabetes patients is not supported by randomised controlled trial (RCT) data. OBJECTIVES:To determine the feasibility of an RCT of glycaemic control with intensive insulin therapy in diabetic foot ulcer, by assessing: entry criteria, fasting capillary blood glucose (FCBG) medication satisfaction and sensitivity of different ulcer-healing endpoints to glycaemic control. DESIGN:Two substudies: one cross-sectional and one single-arm prospective. SETTING:Single-centre secondary care diabetic foot clinic in New Zealand. PARTICIPANTS:Substudy 1: 78 participants consisting of all people ?18 years with a diabetic foot ulcer presenting to the clinic over 35 weeks in 2015.Substudy 2: 15 participants from Substudy 1 consenting to intensive insulin therapy. INTERVENTION:Substudy 1: None.Substudy 2: Intensive insulin therapy with standard podiatry care over 24 weeks. OUTCOME:Substudy 1: Proportion of participants satisfying potential RCT entry criteria; medication satisfaction (Diabetes Medication Satisfaction).Substudy 2: FCBG, index ulcer healing time, index ulcer size, health-related quality of life (HRQoL; EuroQol 5 Dimensions 5 Levels and Diabetic Foot Ulcer Scale-Short Form). RESULTS:Proportion in Substudy 1 satisfying all entry criteria was 31% (95% CI 21 to 42). FCBG values decreased between baseline and study end (difference -3.7 mmol/L, 95% CI -6.5 to -0.8); 83% (95% CI 44 to 95) of ulcers healed by 24 weeks. FCBG correlated negatively with medication satisfaction. Ulcer area logarithm was most sensitive to FCBG changes, displaying significant negative correlation with HRQoL outcomes. Detecting a 30% between-group difference in this outcome (80% power, ?=5%) requires 220 participants per arm, achievable within 1 year with 15 centres similar to study setting. CONCLUSIONS:An adequately powered RCT requires cooperation between a large number of centres. Ulcer area logarithm should be primary endpoint. TRIAL REGISTRATION NUMBER:ANZCTR ACTRN12617001414303.

Dataset Information

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

Publications

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

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