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

• Published in: Diabetes care Vol. 26; no. 10; pp. 2853 - 2859
• Main Authors: Caravaggi, Carlo, De Giglio, Roberto, Pritelli, Chiara, Sommaria, Manuela, Dalla Noce, Sergio, Faglia, Ezio, Mantero, Manuela, Clerici, Giacomo, Fratino, Pietro, Dalla Paola, Luca, Mariani, Giulio, Mingardi, Roberto, Morabito, Alberto
• Format: Journal Article
• Language: English
• Published: United States American Diabetes Association 01-10-2003
• Subjects: Bandages - adverse effects; Care and treatment; Combined Modality Therapy; Dermis - transplantation; Diabetic foot; Diabetic Foot - drug therapy; Diabetic Foot - surgery; Epidermis - transplantation; Foot; Humans; Hyaluronic Acid - administration & dosage; Hyaluronic Acid - adverse effects; Hyaluronic Acid - analogs & derivatives; Infection; Paraffin; Prospective Studies; Skin Transplantation; Transplantation, Autologous; Treatment Outcome; Ulcers; Wound Healing; Italy
• ISSN: 0149-5992
• DOI: 10.2337/diacare.26.10.2853

To evaluate the clinical efficacy and safety of HYAFF 11-based autologous dermal and epidermal grafts in the management of diabetic foot ulcers.
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.
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.
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.