Hyperbaric Oxygen Therapy as Adjunctive Treatment of Chronic Diabetic Foot Ulcers (HODFU)

This study has been completed.
Sponsor:
Collaborators:
Lund University
Region Skåne Sweden
Gorthons Foundation Helsingborg Sweden
Information provided by:
Mrs. Thelma Zoegas Foundation
ClinicalTrials.gov Identifier:
NCT00953186
First received: July 28, 2009
Last updated: November 7, 2011
Last verified: August 2009

July 28, 2009
November 7, 2011
June 2002
May 2009   (final data collection date for primary outcome measure)
Ulcer healing [ Time Frame: 3, 6, 9, 12, 18, 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00953186 on ClinicalTrials.gov Archive Site
  • Amputationrate [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • time to ulcer healing [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • QoL [ Time Frame: 3, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Hyperbaric Oxygen Therapy as Adjunctive Treatment of Chronic Diabetic Foot Ulcers
Hyperbaric Oxygen Therapy as Adjunctive Treatment in Diabetics With Chronic Foot Ulcers

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes
  • Foot Ulcer
  • Healing
  • Device: hyperbaric air
    air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber
  • Device: HBOT
    100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber
  • Active Comparator: HBOT
    100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks
    Intervention: Device: HBOT
  • Placebo Comparator: Placebo
    air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks
    Intervention: Device: hyperbaric air

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
June 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00953186
Z012094
Yes
Magnus Löndahl, MD, Senior consultant, Dept Endocrinology, Lund University Hospital
Mrs. Thelma Zoegas Foundation
  • Lund University
  • Region Skåne Sweden
  • Gorthons Foundation Helsingborg Sweden
Principal Investigator: Magnus Löndahl, MD Inst Clinical Sciences in Lund, Lund University, Sweden
Study Chair: Per L Katzman, ass prof, MD Inst Clinical Sciences in Lund, Lund University, Sweden
Mrs. Thelma Zoegas Foundation
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP