Hyperbaric Oxygen Therapy as Adjunctive Treatment of Chronic Diabetic Foot Ulcers

Phase 4

Completed

• Conditions: Diabetes; Foot Ulcer; Healing
• Interventions: Device: hyperbaric air; Device: HBOT

• Registration Number: NCT00953186
• Lead Sponsor: Mrs. Thelma Zoegas Foundation

Brief Summary

The purpose of this study is to evaluate if hyperbaric oxygen therapy heels more foot ulcers as compared to placebo in patients with diabetes mellitus and chronic foot ulcers.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2009-05
• Study Completion: 2009-06
• Study First Submitted: 2009-07-28
• Status Verified: 2009-08
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Last Update Submitted: 2011-11-07
• Last Update Posted: 2011-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• diabetes mellitus,
• foot ulcer with duration > 3 months,
• treatment at Diabetes foot clinic for > 2 months,
• vascular surgical intervention had not been recommended for the affected lower limb.

Exclusion Criteria

• severe obstructive pulmonary disease,
• malignancy and untreated thyrotoxicosis),
• current drug or alcohol misuse,
• vascular surgery in the lower limbs within the last two months,
• participation in another study or suspected poor compliance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	hyperbaric air	air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks
HBOT	HBOT	100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks

Primary Outcome Measures

Name	Time	Method
Ulcer healing	3, 6, 9, 12, 18, 24 months

Secondary Outcome Measures

Name	Time	Method
Amputationrate	6, 12, 24 months
time to ulcer healing	24 months
QoL	3, 6, 12, 18, 24 months

Trial Locations

Locations (1)

Dept Anesthesiology, Helsingborg Hospital; 🇸🇪 Helsingborg, Sweden