Hyperbaric Oxygen Therapy in the Treatment of Ischemic Lower- Extremity Ulcers in Patients With Diabetes: Results of the DAMO2CLES Multicenter Randomized Clinical Trial
Author:
Santema Katrien T.B.1ORCID, Stoekenbroek Robert M.1, Koelemay Mark J.W.1, Reekers Jim A.2, van Dortmont Laura M.C.3, Oomen Arno4, Smeets Luuk5, Wever Jan J.6, Legemate Dink A.1, Ubbink Dirk T.1, Reichart M., Balm R., Bodegom M.E., van Wanroij J.L., ten Raa S., Willems M.C., Klemm P., de Valk F.G., Wever J.J., Hulst I., de Mol van Otterloo J.C.A., Lenselink E.A., Vos A.W.F., van Nieuwenhuizen R.C., Vahl A.C., Smeets L., Nio D., van den Heuvel J.C.H., Oomen A., Swinkels J., Vriens P.W.H.E., van Hees C.P.A., van Brussel J.P., Koedam N.A., Buijk S., Lauwers P., van Dortmont L.M.C., Nederhoed J.H., Kievit J.K., Wiersema A.M., Vierhout B.P., van Baal J.G., van Hulst R.A., Groot R., Everts P.A.M., Raap R.D. Bol, Boonstra O., Monsieurs K. G., Vellinga T.P. van Rees, Zwinderman A.H., Hamming J.F., Peters E.J.G.,
Affiliation:
1. Department of Surgery, Academic Medical Center, Amsterdam, the Netherlands 2. Department of Radiology, Academic Medical Center, Amsterdam, the Netherlands 3. Department of Surgery, Vlietland Hospital, Schiedam, the Netherlands 4. Department of Surgery, St. Anna Hospital, Geldrop, the Netherlands 5. Department of Surgery, Rijnstate Hospital, Arnhem, the Netherlands 6. Department of Surgery, Haga Hospital, Den Haag, the Netherlands
Abstract
OBJECTIVE
Conflicting evidence exists on the effects of hyperbaric oxygen therapy (HBOT) in the treatment of chronic ischemic leg ulcers. The aim of this trial was to investigate whether additional HBOT would benefit patients with diabetes and ischemic leg ulcers.
RESEARCH DESIGN AND METHODS
Patients with diabetes with an ischemic wound (n = 120) were randomized to standard care (SC) without or with HBOT (SC+HBOT). Primary outcomes were limb salvage and wound healing after 12 months, as well as time to wound healing. Other end points were amputation-free survival (AFS) and mortality.
RESULTS
Both groups contained 60 patients. Limb salvage was achieved in 47 patients in the SC group vs. 53 patients in the SC+HBOT group (risk difference [RD] 10% [95% CI −4 to 23]). After 12 months, 28 index wounds were healed in the SC group vs. 30 in the SC+HBOT group (RD 3% [95% CI −14 to 21]). AFS was achieved in 41 patients in the SC group and 49 patients in the SC+HBOT group (RD 13% [95% CI −2 to 28]). In the SC+HBOT group, 21 patients (35%) were unable to complete the HBOT protocol as planned. Those who did had significantly fewer major amputations and higher AFS (RD for AFS 26% [95% CI 10–38]).
CONCLUSIONS
Additional HBOT did not significantly improve complete wound healing or limb salvage in patients with diabetes and lower-limb ischemia.
Publisher
American Diabetes Association
Subject
Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine
Cited by
113 articles.
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