Diabetes, Foot Ulcer, Healing
Conditions
Keywords
Diabetes, Foot ulcer, Neuropathy, Ischemia
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.
Interventions
DEVICEhyperbaric air
air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber
DEVICEHBOT
100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber
Sponsors
Lund University
Region Skåne Sweden
Gorthons Foundation Helsingborg Sweden
Mrs. Thelma Zoegas Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer healing | 3, 6, 9, 12, 18, 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Amputationrate | 6, 12, 24 months |
| time to ulcer healing | 24 months |
| QoL | 3, 6, 12, 18, 24 months |
Countries
Sweden
Outcome results
None listed