M.bennett at 07:49, 4 April 2022

2022-04-04T07:49:38Z

M.bennett: Created page with " '''Planned RCT to quantify the effect of hyperbaric oxygen therapy for the treatment of diabetic foot ulcer.
2022-04-04T07:45:24Z

Created page with " '''Planned RCT to quantify the effect of hyperbaric oxygen therapy for the treatment of diabetic foot ulcer.</sp..."

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'''Planned RCT to quantify the effect of hyperbaric oxygen therapy for the treatment of diabetic foot ulcer.'''

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'''Clinical Bottom Line'''

None to date

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'''Citation/s: '''1. Lopes JRA, D'Agostino Dias M, Correa JA, Batalha MAB, Guerra LKD.Randomized controlled clinical trial evaluating the efficacy of hyperbaric oxygen therapy in facilitating the healing of chronic foot ulcers in diabetic patients: the study protocol. Trials. 2020 Sep 29;21(1):816. doi: 10.1186/s13063-020-04757-6.  

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'''Lead author's name and fax: '''Reika Lopes: reika.lopes@bol.com.br

'''Three-part Clinical Question:''' For patients with diabetic foot ulcers, does the addition of hyperbaric oxygen therapy to standard treatment approaches, result in improved healing and a reduced rate of amputation? '''Search Terms:''' diabetes; foot ulcer; amputation

'''The Study:''' Single-blinded non-randomised trial with intention-to-treat. '''The Study Patients:''' Diabetic patients with Wagner Grade 2 to 4 foot ulcers persisting for more than a month and no evidence of large vessel arterial disease. '''Control group''' (N = 60; analysed): Standard wound care with dressings, debridement, antibiotics and load relief in an outpatient setting. '''Experimental group''' (N = 60; analysed): As above plus 100% oxygen breathing at 2.5 ATA for 90 minutes daily, Monday to Friday to a total of 35 sessions. Outcome assessor blinded to allocation.

'''The Evidence:'''

Outcomes:  Healing, amputation rate and Quality of Life measure using SF-36.

 

'''Comments:''' 1. Planned study which should have completed recruitment at the end of 2020. 2. No data. Trial registered at a Brazilian site. Registration number RBR-7bd3xy. Registered on 17 July 2019—Retrospectively registered.

'''Appraised by:''' Mike Bennett m.bennett@unsw.edu.au ; Monday, 4 April 2022 '''Kill or Update By:''' April 2025

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	'''Comments:'''<br/> 1. Planned study which should have completed recruitment at the end of 2020.<br/> 2. No data. Trial registered at a Brazilian site. Registration number RBR-7bd3xy. Registered on 17 July 2019—Retrospectively registered.		'''Comments:'''<br/> 1. Planned study which should have completed recruitment at the end of 2020.<br/> 2. No data. Trial registered at a Brazilian site. Registration number RBR-7bd3xy. Registered on 17 July 2019—Retrospectively registered.

−	'''Appraised by:''' Mike Bennett m.bennett@unsw.edu.au ; Monday, 4 April 2022<br/> '''Kill or Update By:''' April 2025	+	'''Appraised by:''' Mike Bennett m.bennett@unsw.edu.au ; Monday, 4 April 2022<br/> '''Kill or Update By:''' April 2025
		+	<p style="text-align: center;">[[File:Sumhorsa.gif\|center\|Sumhorsa.gif]]</p> <p style="text-align: center;"><span style="font-size:xx-large;">'''[[Non-healing_wounds\|BACK]]'''</span></p>