BACKGROUND: Lower extremity ulcers are a serious complication of diabetes mellitus (DM). These ulcers show decreased angiogenic response and production of growth factors. Recombinant human platelet derived growth factor (rhPDGF) has been found to decrease the time to healing. This study was conducted to evaluate its efficacy in the treatment of diabetic foot ulcers. METHODS: A total of 50 patients with type 1 or type 2 DM and chronic ulcers, of at least 4 weeks duration, were studied. They were randomised into two groups, of 25 patients each. The patients in group 'A' (test group) received treatment with topical application of rhPDGF gel and those in group 'B' (control group) were treated with local application of KY Jelly as a placebo. A standardised regimen of good wound care was provided to both groups. Healing or reduction in size of the wound, over a period of 10 weeks after commencement of treatment was recorded. RESULTS: The mean age of the patients was 49.9 years in the control group and 56.2 years in test group. The median duration of ulcer at time of enrolment in the study was 6 weeks in control and 5 weeks in test group. Fifteen ulcers in control group belonged to IAET (International Association of Enterostomal Therapy) class III and 10 ulcers to class IV where as 16 ulcers were in IAET class III and 9 ulcers in IAET class IV in the test group. The mean size of the wounds was 26.5 ± 2.5 cm(2) in control group and 29.9 ± 3.4 cm2 in test group. All patients tolerated the test medication well. At the end of 10 weeks, 18 (72%) ulcers had healed in control group and 15 (60%) in test group (p > 0.05). Three ulcers in control group showed >75% reduction in size compared to 2 in the test group (p > 0.05). CONCLUSION: This study did not show any statistically significant improvement in ulcer healing rates after the use of topically applied rhPDGF.
RCT Entities:
BACKGROUND: Lower extremity ulcers are a serious complication of diabetes mellitus (DM). These ulcers show decreased angiogenic response and production of growth factors. Recombinant human platelet derived growth factor (rhPDGF) has been found to decrease the time to healing. This study was conducted to evaluate its efficacy in the treatment of diabetic foot ulcers. METHODS: A total of 50 patients with type 1 or type 2 DM and chronic ulcers, of at least 4 weeks duration, were studied. They were randomised into two groups, of 25 patients each. The patients in group 'A' (test group) received treatment with topical application of rhPDGF gel and those in group 'B' (control group) were treated with local application of KY Jelly as a placebo. A standardised regimen of good wound care was provided to both groups. Healing or reduction in size of the wound, over a period of 10 weeks after commencement of treatment was recorded. RESULTS: The mean age of the patients was 49.9 years in the control group and 56.2 years in test group. The median duration of ulcer at time of enrolment in the study was 6 weeks in control and 5 weeks in test group. Fifteen ulcers in control group belonged to IAET (International Association of Enterostomal Therapy) class III and 10 ulcers to class IV where as 16 ulcers were in IAET class III and 9 ulcers in IAET class IV in the test group. The mean size of the wounds was 26.5 ± 2.5 cm(2) in control group and 29.9 ± 3.4 cm2 in test group. All patients tolerated the test medication well. At the end of 10 weeks, 18 (72%) ulcers had healed in control group and 15 (60%) in test group (p > 0.05). Three ulcers in control group showed >75% reduction in size compared to 2 in the test group (p > 0.05). CONCLUSION: This study did not show any statistically significant improvement in ulcer healing rates after the use of topically applied rhPDGF.
Authors: Michael M Engelgau; Linda S Geiss; Jinan B Saaddine; James P Boyle; Stephanie M Benjamin; Edward W Gregg; Edward F Tierney; Nilka Rios-Burrows; Ali H Mokdad; Earl S Ford; Giuseppina Imperatore; K M Venkat Narayan Journal: Ann Intern Med Date: 2004-06-01 Impact factor: 25.391
Authors: Maria José Martinez-Zapata; Arturo J Martí-Carvajal; Ivan Solà; José Angel Expósito; Ignasi Bolíbar; Luciano Rodríguez; Joan Garcia; Carlos Zaror Journal: Cochrane Database Syst Rev Date: 2016-05-25