Abstract | OBJECTIVE: To evaluate the clinical efficacy and safety of HYAFF 11-based autologous dermal and epidermal grafts in the management of diabetic foot ulcers. RESEARCH DESIGN AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
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Authors | Carlo Caravaggi, Roberto De Giglio, Chiara Pritelli, Manuela Sommaria, Sergio Dalla Noce, Ezio Faglia, Manuela Mantero, Giacomo Clerici, Pietro Fratino, Luca Dalla Paola, Giulio Mariani, Roberto Mingardi, Alberto Morabito |
Journal | Diabetes care
(Diabetes Care)
Vol. 26
Issue 10
Pg. 2853-9
(Oct 2003)
ISSN: 0149-5992 [Print] United States |
PMID | 14514591
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- hyaluronic acid benzyl ester
- Paraffin
- Hyaluronic Acid
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Topics |
- Bandages
(adverse effects)
- Combined Modality Therapy
- Dermis
(transplantation)
- Diabetic Foot
(drug therapy, surgery)
- Epidermis
(transplantation)
- Humans
- Hyaluronic Acid
(administration & dosage, adverse effects, analogs & derivatives)
- Infections
- Paraffin
- Prospective Studies
- Skin Transplantation
- Transplantation, Autologous
- Treatment Outcome
- Wound Healing
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