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HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers: a prospective, multicenter, controlled, randomized clinical trial.
- Source :
-
Diabetes Care . Oct2003, Vol. 26 Issue 10, p2853-2859. 7p. 4 Charts, 1 Graph. - Publication Year :
- 2003
-
Abstract
- <bold>Objective: </bold>To evaluate the clinical efficacy and safety of HYAFF 11-based autologous dermal and epidermal grafts in the management of diabetic foot ulcers.<bold>Research Design and Methods: </bold>A total of 79 patients with diabetic dorsal (n = 37) or plantar (n = 42) ulcers were randomized to either the control group with nonadherent paraffin gauze (n = 36) or the treatment group with autologous tissue-engineered grafts (n = 43). Weekly assessment, aggressive debridement, wound infection control, and adequate pressure relief (fiberglass off-loading cast for plantar ulcers) were provided in both groups. Complete wound healing was assessed within 11 weeks. Safety was monitored by adverse events.<bold>Results: </bold>Complete ulcer healing was achieved in 65.3% of the treatment group and 49.6% of the control group (P = 0.191). The Kaplan-Meier mean time to closure was 57 and 77 days, respectively, for the treatment versus control groups. Plantar foot ulcer healing was 55% and 50% in the treatment and control groups, respectively. Dorsal foot ulcer healing was significantly different, with 67% in the treatment group and 31% in the control group (P = 0.049). The mean healing time in the dorsal treatment group was 63 days, and the odds ratio for dorsal ulcer healing compared with the control group was 4.44 (P = 0.037). Adverse events were equally distributed between the two groups, and none were related to the treatments.<bold>Conclusions: </bold>The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing. For plantar ulcers, the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment. This treatment, however, may be useful in patients for whom the total off-loading cast is not recommended and only a less effective off-loading device can be applied. [ABSTRACT FROM AUTHOR]
- Subjects :
- *ULCER treatment
*PEOPLE with diabetes
*DISEASES
Subjects
Details
- Language :
- English
- ISSN :
- 01495992
- Volume :
- 26
- Issue :
- 10
- Database :
- Academic Search Index
- Journal :
- Diabetes Care
- Publication Type :
- Academic Journal
- Accession number :
- 11046933
- Full Text :
- https://doi.org/10.2337/diacare.26.10.2853