THE USE OF PHOTOTHERAPY AND PODIATRIC INTERVENTION TO MANAGE CHRONIC LOWER LIMB ULCERATIONS IN PATIENTS WITH TYPE II DIABETES MELLITUS: A PILOT STUDY
- Conditions
- Nutritional, Metabolic, EndocrineDiabetic
- Registration Number
- PACTR201203000367225
- Lead Sponsor
- niversity of Johannesburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 15
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method