Nutritional, Metabolic, Endocrine Diabetic
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Type II diabetes with neuropathic or mixed (venous and arterial) ulcers, 2) lower extremity ulcer, 3) stable or worsening ulcer which has been present for a minimum of 4 weeks, 4) willingness to participate and commitment to the study, and 5) signed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1) Evidence of acute cellulitis, osteomyelitis or gangrene anywhere in the affected extremity, 2) presence of any of one or more medical conditions including renal, hepatic, hematologic, neurologic, or immune disease not related to diabetes, 3) presence of malignant disease (other than basal cell carcinoma) not in remission for more than 5 years, 4) use of oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents, 5) known infection with HIV or presence of AIDS, 6) use of other investigational drug or device within 30 days of recruitment into the study, and 7) other leg ulcers, such as ulcers due to decubiti or vasculitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establishing whether phototherapy improves the rate of wound healing of diabetic lower limb ulcers in combination with podiatric management | — |
Secondary
| Measure | Time frame |
|---|---|
| Establish if phototherapy of diabetic ulcers as well as lymph nodes speeds up the healing process | — |
Countries
South Africa
Contacts
HOD, Laser Research Centre, Faculty of Health Sciences, University of Johannesburg