Santema KTB, Stoekenbroek RM, Koelemay MJW, Reekers JA, van Dortmont LMC, Oomen A, Smeets L, Wever JJ, Legemate DA, Ubbink DT, DAMO2CLES Study Group., et al.
Diabetes care. Date of publication 2018 Jan 1;volume 41(1):112-119.
1. Diabetes Care. 2018 Jan;41(1):112-119. doi: 10.2337/dc17-0654. Epub 2017 Oct 26.
Hyperbaric Oxygen Therapy in the Treatment of Ischemic Lower- Extremity Ulcers in
Patients With Diabetes: Results of the DAMO2CLES Multicenter Randomized Clinical
Trial.
Santema KTB(1), Stoekenbroek RM(1), Koelemay MJW(1), Reekers JA(2), van Dortmont
LMC(3), Oomen A(4), Smeets L(5), Wever JJ(6), Legemate DA(1), Ubbink DT(7);
DAMO2CLES Study Group.
Collaborators: Reichart M, Balm R, Bodegom ME, van Wanroij JL, Ten Raa S, Willems
MC, Klemm P, de Valk FG, Wever JJ, Hulst I, de Mol van Otterloo JCA, Lenselink
EA, Vos AWF, van Nieuwenhuizen RC, Vahl AC, Smeets L, Nio D, van den Heuvel JCH,
Oomen A, Swinkels J, Vriens PWHE, van Hees CPA, van Brussel JP, Koedam NA, Buijk
S, Lauwers P, van Dortmont LMC, Nederhoed JH, Kievit JK, Wiersema AM, Vierhout
BP, van Baal JG, van Hulst RA, Groot R, Everts PAM, Raap RDB, Boonstra O,
Monsieurs KG, Vellinga TPVR, Zwinderman AH, Hamming JF, Peters EJG.
Author information:
(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.
(7)Department of Surgery, Academic Medical Center, Amsterdam, the Netherlands
d.ubbink@amc.nl.
Comment in
Diabetes Care. 2018 Apr;41(4):e60.
Diabetes Care. 2018 Apr;41(4):e61.
Diabetes Care. 2018 Apr;41(4):e62-e63.
Ann Transl Med. 2018 Jun;6(11):228.
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.
© 2017 by the American Diabetes Association.
DOI: 10.2337/dc17-0654
PMID: 29074815 [Indexed for MEDLINE]
