Hyperbaric Oxygen Therapy as Adjunctive Treatment of Chronic Diabetic Foot Ulcers (HODFU)
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ClinicalTrials.gov Identifier: NCT00953186 |
Recruitment Status :
Completed
First Posted : August 6, 2009
Last Update Posted : November 8, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Foot Ulcer Healing | Device: hyperbaric air Device: HBOT | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 94 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Hyperbaric Oxygen Therapy as Adjunctive Treatment in Diabetics With Chronic Foot Ulcers |
Study Start Date : | June 2002 |
Actual Primary Completion Date : | May 2009 |
Actual Study Completion Date : | June 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: HBOT
100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks
|
Device: HBOT
100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber |
Placebo Comparator: Placebo
air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks
|
Device: hyperbaric air
air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber |
- Ulcer healing [ Time Frame: 3, 6, 9, 12, 18, 24 months ]
- Amputationrate [ Time Frame: 6, 12, 24 months ]
- time to ulcer healing [ Time Frame: 24 months ]
- QoL [ Time Frame: 3, 6, 12, 18, 24 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953186
Sweden | |
Dept Anesthesiology, Helsingborg Hospital | |
Helsingborg, Sweden, S 221 57 |
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Magnus Löndahl, MD, Senior consultant, Dept Endocrinology, Lund University Hospital |
ClinicalTrials.gov Identifier: | NCT00953186 |
Other Study ID Numbers: |
Z012094 |
First Posted: | August 6, 2009 Key Record Dates |
Last Update Posted: | November 8, 2011 |
Last Verified: | August 2009 |
Diabetes Foot ulcer Neuropathy Ischemia |
Foot Ulcer Ulcer Pathologic Processes Foot Diseases |
Skin Diseases Leg Ulcer Skin Ulcer |