Hyperbaric Oxygen Therapy in the Treatment of Ischemic Lower- Extremity Ulcers in Patients With Diabetes: Results of the DAMO(2)CLES Multicenter Randomized Clinical Trial

AUTHOR GROUP

doi:https://doi.org/10.2337/dc17-0654

Hyperbaric Oxygen Therapy in the Treatment of Ischemic Lower- Extremity Ulcers in Patients With Diabetes: Results of the DAMO(2)CLES Multicenter Randomized Clinical Trial

AUTHOR GROUP

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Abstract

OBJECTIVEConflicting 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 METHODSPatients 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.RESULTSBoth 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]).CONCLUSIONSAdditional HBOT did not significantly improve complete wound healing or limb salvage in patients with diabetes and lower-limb ischemia

Original language	English
Pages (from-to)	112-119
Number of pages	8
Journal	Diabetes care
Volume	41
Issue number	1
Early online date	2017
DOIs	https://doi.org/10.2337/dc17-0654
Publication status	Published - 1 Jan 2018

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@article{453503cb983c46fb87d77006f5132a2e,

title = "Hyperbaric Oxygen Therapy in the Treatment of Ischemic Lower- Extremity Ulcers in Patients With Diabetes: Results of the DAMO(2)CLES Multicenter Randomized Clinical Trial",

abstract = "OBJECTIVEConflicting 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 METHODSPatients 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.RESULTSBoth 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]).CONCLUSIONSAdditional HBOT did not significantly improve complete wound healing or limb salvage in patients with diabetes and lower-limb ischemia",

author = "Santema, {Katrien T. B.} and Stoekenbroek, {Robert M.} and Koelemay, {Mark J. W.} and Reekers, {Jim A.} and {van Dortmont}, {Laura M. C.} and Arno Oomen and Luuk Smeets and Wever, {Jan J.} and Legemate, {Dink A.} and Ubbink, {Dirk T.} and {AUTHOR GROUP} and M. Reichart and R. Balm and Bodegom, {M. E.} and {van Wanroij}, {J. L.} and {ten Raa}, S. and Willems, {M. C.} and P. Klemm and {de Valk}, {F. G.} and Wever, {J. J.} and I. Hulst and {de Mol van Otterloo}, {J. C. A.} and Lenselink, {E. A.} and Vos, {A. W. F.} and {van Nieuwenhuizen}, {R. C.} and Vahl, {A. C.} and L. Smeets and D. Nio and {van den Heuvel}, {J. C. H.} and A. Oomen and J. Swinkels and Vriens, {P. W. H. E.} and {van Hees}, {C. P. A.} and {van Brussel}, {J. P.} and Koedam, {N. A.} and S. Buijk and P. Lauwers and {van Dortmont}, {L. M. C.} and Nederhoed, {J. H.} and Kievit, {J. K.} and Wiersema, {A. M.} and Vierhout, {B. P.} and {van Baal}, {J. G.} and {van Hulst}, {R. A.} and R. Groot and Everts, {P. A. M.} and Raap, {R. D. Bol} and O. Boonstra and Monsieurs, {K. G.} and Vellinga, {T. P. Van Rees} and Zwinderman, {A. H.}",

year = "2018",

month = jan,

day = "1",

doi = "https://doi.org/10.2337/dc17-0654",

language = "English",

volume = "41",

pages = "112--119",

journal = "Diabetes care",

issn = "0149-5992",

publisher = "American Diabetes Association Inc.",

number = "1",

}

TY - JOUR

T1 - Hyperbaric Oxygen Therapy in the Treatment of Ischemic Lower- Extremity Ulcers in Patients With Diabetes

T2 - Results of the DAMO(2)CLES Multicenter Randomized Clinical Trial

AU - Santema, Katrien T. B.

AU - Stoekenbroek, Robert M.

AU - Koelemay, Mark J. W.

AU - Reekers, Jim A.

AU - van Dortmont, Laura M. C.

AU - Oomen, Arno

AU - Smeets, Luuk

AU - Wever, Jan J.

AU - Legemate, Dink A.

AU - Ubbink, Dirk T.

AU - AUTHOR GROUP

AU - Reichart, M.

AU - Balm, R.

AU - Bodegom, M. E.

AU - van Wanroij, J. L.

AU - ten Raa, S.

AU - Willems, M. C.

AU - Klemm, P.

AU - de Valk, F. G.

AU - Wever, J. J.

AU - Hulst, I.

AU - de Mol van Otterloo, J. C. A.

AU - Lenselink, E. A.

AU - Vos, A. W. F.

AU - van Nieuwenhuizen, R. C.

AU - Vahl, A. C.

AU - Smeets, L.

AU - Nio, D.

AU - van den Heuvel, J. C. H.

AU - Oomen, A.

AU - Swinkels, J.

AU - Vriens, P. W. H. E.

AU - van Hees, C. P. A.

AU - van Brussel, J. P.

AU - Koedam, N. A.

AU - Buijk, S.

AU - Lauwers, P.

AU - van Dortmont, L. M. C.

AU - Nederhoed, J. H.

AU - Kievit, J. K.

AU - Wiersema, A. M.

AU - Vierhout, B. P.

AU - van Baal, J. G.

AU - van Hulst, R. A.

AU - Groot, R.

AU - Everts, P. A. M.

AU - Raap, R. D. Bol

AU - Boonstra, O.

AU - Monsieurs, K. G.

AU - Vellinga, T. P. Van Rees

AU - Zwinderman, A. H.

PY - 2018/1/1

Y1 - 2018/1/1

N2 - OBJECTIVEConflicting 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 METHODSPatients 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.RESULTSBoth 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]).CONCLUSIONSAdditional HBOT did not significantly improve complete wound healing or limb salvage in patients with diabetes and lower-limb ischemia

AB - OBJECTIVEConflicting 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 METHODSPatients 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.RESULTSBoth 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]).CONCLUSIONSAdditional HBOT did not significantly improve complete wound healing or limb salvage in patients with diabetes and lower-limb ischemia

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U2 - https://doi.org/10.2337/dc17-0654

DO - https://doi.org/10.2337/dc17-0654

M3 - Article

C2 - 29074815

SN - 0149-5992

VL - 41

SP - 112

EP - 119

JO - Diabetes care

JF - Diabetes care

IS - 1

ER -

Hyperbaric Oxygen Therapy in the Treatment of Ischemic Lower- Extremity Ulcers in Patients With Diabetes: Results of the DAMO(2)CLES Multicenter Randomized Clinical Trial

Abstract

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