Hyperbaric oxygen therapy in the treatment of ischemic lower- extremity ulcers in patients with diabetes: results of the DAMO2CLES multicenter randomized clinical trial.
Open accessAbstract
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: = 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.
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Negative pressure wound therapy has been widely used as an adjunct therapy in the treatment of complicated and postoperative wounds in the diabetic foot for the last 2 decades.
“Negative pressure wound therapy has been widely used as an adjunct therapy in the treatment of complicated and postoperative wounds in the diabetic foot for the last 2 decades. 52,64”
From Diabetic Foot Ulcers (2023) · cites this paper as [64]
The Abstract discusses hyperbaric oxygen therapy as an adjunct to diabetic foot-ulcer care, not negative pressure wound therapy. Searches for “negative pressure wound therapy” and “vacuum-assisted closure” found no passage addressing its use for complicated or postoperative diabetic foot wounds, or the claimed two-decade history. (LLM, conf=0.76)
Experimental — accuracy not yet measuredDressing selection based on wound characteristics promotes a moist environment conducive to tissue growth and epithelial migration.
“Dressing selection Based on wound characteristics, ie, location, inflammation, and amount of exudate Promote a moist environment conducive to tissue growth and epithelial migration.63,64”
From Diabetic Foot Ulcers (2023) · cites this paper as [64]
The Interventions section (page unavailable) says patients received local wound treatment, and Data Collection and Outcome Measures (page unavailable) defines healing as complete reepithelization. Neither addresses how dressings were selected or whether they maintained moisture to promote tissue growth and epithelial migration. Searches for dressing selection, exudate, moisture, and epithelial migration found no supporting passage. (LLM, conf=0.76)
Experimental — accuracy not yet measuredIn a meta-analysis of 943 patients, negative pressure wound therapy improved healing compared with standard moisture-balancing dressings (odds ratio, 3.60; 95% CI, 2.38-5.45; P < .001).
“Negative pressure wound therapy Used in treatment of complicated and postoperative wounds in the diabetic foot Improved healing in a meta-analysis of 943 patients who received negative pressure wound therapy vs standard moisture-balancing dressings (odds ratio, 3.60; 95% CI, 2.38-5.45;P < .001).”
From Diabetic Foot Ulcers (2023) · cites this paper as [64]
The Complete Wound Healing section reports a 120-patient trial comparing standard care with standard care plus hyperbaric oxygen therapy, not negative pressure wound therapy. Searches for the 943-patient meta-analysis, moisture-balancing dressings, and the stated odds ratio found no passage addressing the claim in our copy; page numbers were unavailable. (LLM, conf=0.78)
Experimental — accuracy not yet measuredNegative pressure wound therapy is effective in resolving wound depth.
“Effective in resolving wound depth.64,[73][74][75]”
From Diabetic Foot Ulcers (2023) · cites this paper as [64]
The Interventions and Complete Wound Healing sections describe hyperbaric oxygen therapy and report wound-healing outcomes, not the effectiveness of negative pressure wound therapy. Searches for negative pressure wound therapy, vacuum-assisted closure, and wound depth found no passage addressing the claim. Page numbers were not available in our copy. (LLM, conf=0.76)
Experimental — accuracy not yet measured
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- Authors
- Santema, K. T. B., Stoekenbroek, R. M., Koelemay, M. J. W., Reekers, J. A., van Dortmont, L. M. C., Oomen, A., Smeets, L., Wever, J. J., Legemate, D. A., Ubbink, D. T., DAMO2CLES Study Group, 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. B., Boonstra, O., Monsieurs, K. G., Vellinga, T. P. V. R., Zwinderman, A. H., Hamming, J. F., & Peters, E. J. G.
- Affiliations
- Amsterdam UMC Location University of Amsterdam (NL)
- Department of Surgery, Vlietland Hospital, Schiedam, the Netherlands
- St. Anna Ziekenhuis (NL)
- Department of Surgery, Rijnstate Hospital, Arnhem, the Netherlands
- Department of Surgery, Haga Hospital, Den Haag, the Netherlands
- Corresponding author
- Ubbink, Dirk T.
- DAMO2CLES Study Group
- ORCID
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2017-10-26
- Volume
- 41
- Issue
- 1
- Pages
- 112-119
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W2765204585
- Cited by
- 170
- References
- 25
- Citations by year
- 2026: 11 · 2025: 15 · 2024: 18 · 2023: 20 · 2022: 16 · 2021: 23 · 2020: 34 · 2019: 18 · 2018: 14 · 2017: 1
- FWCI
- 14.49
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- ZonMw (83700.2005)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetic Foot Ulcer Assessment and Management
- Health Sciences › Medicine › Surgery › Peripheral Artery Disease Management
- Health Sciences › Medicine › Rehabilitation › Wound Healing and Treatments
- Keywords
- hyperbaric oxygen therapy, diabetic foot ulcer, limb salvage, wound healing, amputation-free survival, major amputation, lower limb ischemia, diabetes mellitus
- MeSH terms
- Aged, Aged, 80 and over, Amputation, Surgical, Diabetes Mellitus, Type 2, Female, Follow-Up Studies, Humans, Hyperbaric Oxygenation, Ischemia, Male, Middle Aged, Ulcer, Wound Healing, Body Mass Index, Treatment Outcome, Sample Size, Limb Salvage
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