Diabetic Foot Ulcers

Laura Bolton, PhD

Dear Readers: Foot problems are the most frequent cause of hospitalization in diabetic patients. Peripheral neuropathy leads to loss of protective sensation, and unheeded trauma results in ulceration with a high potential for infection and amputation. Consistent offloading has reportedly healed up to 80 percent of diabetic foot ulcers within 10 weeks,1 but patient adherence to the offloading protocols is inconsistent, and the total contact casts, which assure adherence to achieve these sterling results, require skill to apply. Below are two recent additions to the continuing search for topical modalities to heal these difficult wounds, identifying one debridement modality with healing benefits. While the search for effective topical care continues, clinicians face the challenge of offloading pressure points on the plantar surface consistently and well. Without effective offloading, topical treatment makes small headway against repeated trauma of the patient’s weight on the affected foot surface.

Laura L. Bolton, PhD
Department Editor

Randomized Controlled Trial of Collagen/Oxidized Regenerated Cellulose Dressing

Reference: Veves A, Sheehan P, Pham HT, for the Promogran® Diabetic Foot Ulcer Study. A randomized, controlled trial of Promogran (a collagen/oxidized regenerated cellulose dressing) vs. standard treatment in the management of diabetic foot ulcers. Arch Surg 2002;137:822–7.

Rationale: Primary dressings are needed that might afford healing benefits for diabetic foot ulcers better than the effects of standard primary dressing with moistened gauze.

Objective: This study compared the effect of a collagen/oxidized regenerated cellulose dressing (C/ORC) versus saline-moistened gauze primary dressings on complete wound closure of foot ulcers of diabetic patients being treated in university teaching hospitals and primary care centers.

Methods: After a baseline medical history, which included reporting ulcer duration, type and prior management, and patient activity level and ambulatory status, 138 patients were randomly assigned to each dressing group, receiving either saline-moistened gauze or C/ORC dressing. Offloading techniques were standardized to the accepted protocol within the center but varied between centers. Both dressings were changed when clinically required for a maximum period of 12 weeks. Healing efficacy, safety, and patient and physician preferences were recorded.

Results: There were no significant differences in safety and efficacy of the two dressings, with 90 percent of patients in both groups adhering to the protocol. Among the C/ORC-dressed ulcers, 37 percent healed after 12 weeks as compared to 28.3 percent of moist gauze-dressed ulcers
(p = 0.12). In the subset of ulcers with lower than six-month duration, 45 percent of the 95 C/ORC-dressed ulcers healed at 12 weeks, as compared to 33 percent of 89 moist gauze-dressed ulcers (p = 0.056). Both patients and physicians preferred the C/ORC dressings.

Conclusions: As a primary dressing on diabetic foot ulcers, the C/ORC dressing was comparable in safety and healing effects to saline-moistened gauze, though both patients and physicians preferred C/ORC.

Clinical perspective: In clinical studies of wound healing on diabetic patients with plantar ulcers, there can be wide variability in the wound response to different offloading techniques or patient adherence to these offloading regimens, as well as blood glucose control and peripheral circulation differences. These sources of variability can overshadow effects of primary wound dressings on wound outcomes, a fact that alerts clinicians to the value of quality, consistent offloading of the diabetic lower extremity.

Evidence Summary: Healing Effects of Diabetic Foot Debridement

Reference: Smith J. Debridement of diabetic foot ulcers (Cochrane Review).

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