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Autologous platelet-rich gel for treatment of diabetic chronic refractory cutaneous ulcers: A prospective, randomized clinical trial.
- Source :
- Wound Repair & Regeneration; Jul/Aug2015, Vol. 23 Issue 4, p495-505, 11p
- Publication Year :
- 2015
-
Abstract
- The purpose of the study is to examine the safety and effectiveness of topical autologous platelet-rich gel (APG) application on facilitating the healing of diabetic chronic refractory cutaneous ulcers. The study was designed as a prospective, randomized controlled trial between January 1, 2007 and December 31, 2011. Eligible inpatients at the Diabetic Foot Care Center of West China Hospital, Sichuan University (China) were randomly prescribed with a 12-week standard treatment of ulcers (the control group) or standard treatment plus topical application APG (the APG group). The wound healing grades (primary endpoint), time to complete healing, and healing velocity within 12 weeks were monitored as short-term effectiveness measurements, while side effects were documented safety endpoints. The rates of survival and recurrence within the follow up were recorded as long-term effectiveness endpoints. Analysis on total diabetic ulcers (DUs) ( n = 117) and subgroup analysis on diabetic foot ulcers (DFUs) ( n = 103) were both conducted. Standard treatment plus APG treatment was statistically more effective than standard treatment ( p < 0.05 in both total DUs and subgroup of DFUs). The subjects defined as healing grade 1 were 50/59 (84.8%) in total DUs and 41/48 (85.4%) in DFUs in the APG group compared with 40/58 (69.0%) and 37/55 (67.3%) in the control group from intent to treat population. The Kaplan-Meier time-to-healing were significantly different between the two groups ( p < 0.05 in both total DUs and subgroup of DFUs). No side effects were identified after topical APG application. The long-term survival and recurrence rates were comparative between groups ( p > 0.05). This study shows that topical APG application plus standard treatment is safe and quite effective on diabetic chronic refractory cutaneous ulcers, compared with standard treatment. [ABSTRACT FROM AUTHOR]
- Subjects :
- DIABETES complications
ACADEMIC medical centers
CHI-squared test
LONGITUDINAL method
RESEARCH funding
T-test (Statistics)
DIABETIC foot
RANDOMIZED controlled trials
CHRONIC wounds & injuries
DATA analysis software
DESCRIPTIVE statistics
KAPLAN-Meier estimator
PLATELET-rich plasma
LOG-rank test
MANN Whitney U Test
Subjects
Details
- Language :
- English
- ISSN :
- 10671927
- Volume :
- 23
- Issue :
- 4
- Database :
- Complementary Index
- Journal :
- Wound Repair & Regeneration
- Publication Type :
- Academic Journal
- Accession number :
- 109217102
- Full Text :
- https://doi.org/10.1111/wrr.12294