on-weight bearing exercise in people with diabetes and foot complications
Phase 1
Not yet recruiting
- Conditions
- Diabetic foot ulcersMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12606000426583
- Lead Sponsor
- Austin Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
All attending the Austin Health’s High Risk Foot Clinic (HRFC) with a chronic (> six weeks) foot ulcer and diabetes that are physically capable of undertaking exercise, as decided by local medical officer, endocrinologist and/or research exercise physiologist.
Exclusion Criteria
Patients with diagnosed osteomyelitis; Patients with frank gangrene;Patients who are unlikely to survive for the duration of the study, such as those who have very low creatinine clearance, and those with advanced malignant cancer;Patients involved in any study affecting glycaemic control, or any factors that could affect wound healing.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wound healing rate[Measured at week 0, and every 4 weeks until healed or until week 20 (whichever occurs first).]
- Secondary Outcome Measures
Name Time Method HbA1c, body mass index[Measured week 0, week 10 and week 20.];Quality of life[Assessed at week 0 and week 20.];Wound substrate changes[Measured at week 0 and just prior to healing or week 20, whichever comes first.]