Effect of noncontact normothermic wound therapy on the healing of neuropathic (diabetic) foot ulcers: an interim analysis of 20 patients.

This is the interim analysis of a prospective, randomized, controlled study comparing diabetic foot ulcer healing in patients being treated with either noncontact normothermic wound therapy (Warm-UP; Augustine Medical Inc. Eden Prairie, MN) applied for 1 hour 3 times daily until healing or 12 weeks, or standard care (saline-moistened gauze applied once a day). Surgical debridement and adequate foot off-loading was provided to both groups. Evaluations were performed weekly and consisted of acetate tracings, wound assessment, and serial photography. Twenty patients have completed the trial and both treatment groups were distributed evenly (N = 10). Ulcers treated with noncontact normothermic wound therapy had a greater mean percent wound closure than control-treated ulcers at each evaluation point (weeks 1-12). After 12 weeks, 70% of the wounds treated with noncontact normothermic wound therapy were healed compared with 40% for the control group. In this subset of patients there have been no adverse events associated with noncontact normothermic wound therapy.

RCT Entities:   Population Interventions Outcomes