Hyperbaric Oxygen Therapy as Adjunctive Treatment of Chronic Diabetic Foot Ulcers

Diabetes Clinical Trial

— HODFU  

Official title:

Hyperbaric Oxygen Therapy as Adjunctive Treatment in Diabetics With Chronic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00953186
• Other study ID #: Z012094
• Status: Completed
• Phase: Phase 4
• First received: July 28, 2009
• Last updated: November 7, 2011
• Start date: June 2002
• Est. completion date: June 2009

Study information

• Verified date: August 2009
• Source: Mrs. Thelma Zoegas Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSweden: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Foot Ulcer
• Healing
• Ulcer

Intervention

Device:
• hyperbaric air
air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber
• HBOT
100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber

Locations

Country	Name	City	State
Sweden	Dept Anesthesiology, Helsingborg Hospital	Helsingborg

Sponsors (4)

Lead Sponsor	Collaborator
Mrs. Thelma Zoegas Foundation	Gorthons Foundation Helsingborg Sweden, Lund University, Region Skåne Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Löndahl M, Katzman P, Nilsson A, Hammarlund C, Sellman A, Wykman A, Hugo-Persson M, Apelqvist J. A prospective study: hyperbaric oxygen therapy in diabetics with chronic foot ulcers. J Wound Care. 2006 Nov;15(10):457-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ulcer healing		3, 6, 9, 12, 18, 24 months	No
Secondary	Amputationrate		6, 12, 24 months	No
Secondary	time to ulcer healing		24 months	No
Secondary	QoL		3, 6, 12, 18, 24 months	No