Non-weight bearing exercise in people with diabetes and foot complications

A structured, non weight bearing exercise program to improve glycaemic control, wound healing and quality of life in people with foot complications due to diabetes

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000426583

Enrollment

Registered

2006-10-03

Start date

2006-02-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We aim to assess whether undertaking a structured, non-weightbearing exercise program over 20 weeks will accelerate healing in people with chronic diabetic foot ulcers. We also aim to assess whether this program improves glycaemic control, body mass index, wound bed substrate and quality of life.

Interventions

Intervention group will be undertaking non-weight-bearing exercise three times a week over 20 weeks. The exercise will include resistance training and cardiovascular activities, however these will be undertaken without plantar foot pressure occuring.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results