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| Name | Class |
|---|---|
| Lund University | OTHER |
| Region Skåne Sweden | OTHER_GOV |
| Gorthons Foundation Helsingborg Sweden | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBOT | Active Comparator | 100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks |
|
| Placebo | Placebo Comparator | air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyperbaric air | Device | air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ulcer healing | 3, 6, 9, 12, 18, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Amputationrate | 6, 12, 24 months | |
| time to ulcer healing | 24 months | |
| QoL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magnus Löndahl, MD | Inst Clinical Sciences in Lund, Lund University, Sweden | Principal Investigator |
| Per L Katzman, ass prof, MD | Inst Clinical Sciences in Lund, Lund University, Sweden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept Anesthesiology, Helsingborg Hospital | Helsingborg | S 221 57 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17124820 | Background | Londahl 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. doi: 10.12968/jowc.2006.15.10.26970. | |
| 20957342 | Derived | Londahl M, Katzman P, Hammarlund C, Nilsson A, Landin-Olsson M. Relationship between ulcer healing after hyperbaric oxygen therapy and transcutaneous oximetry, toe blood pressure and ankle-brachial index in patients with diabetes and chronic foot ulcers. Diabetologia. 2011 Jan;54(1):65-8. doi: 10.1007/s00125-010-1946-y. Epub 2010 Oct 19. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D016523 | Foot Ulcer |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| HBOT | Device | 100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber |
|
| 3, 6, 12, 18, 24 months |
| 20427683 | Derived | Londahl M, Katzman P, Nilsson A, Hammarlund C. Hyperbaric oxygen therapy facilitates healing of chronic foot ulcers in patients with diabetes. Diabetes Care. 2010 May;33(5):998-1003. doi: 10.2337/dc09-1754. |
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |