The treatment of foot problems in patients with diabetes or reduced blood flow to the legs

Not Applicable

Recruiting

• Conditions: type 1 diabetes mellitus; type 2 diabetes mellitus; peripheral arterial disease; Lower limb ulceration; lower limb gangrene; Lower limb rest pain; Metabolic and Endocrine - Diabetes; Skin - Other skin conditions; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12621000337875
• Lead Sponsor: Dr Odette Hart

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-25
• Last Update Posted: 29 March 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

The inclusion criteria are those over 18 years old experiencing diabetic foot disease as defined as a diagnosis of diabetes mellitus and with lower limb infection, ulceration, non-healing surgical wounds, gangrene, peripheral neuropathy, lower limb rest pain, or foot deformity; or CLTI alone, as defined as peripheral artery disease with lower limb rest pain, gangrene or ulceration of greater than two-week duration in a person without a diagnosis of diabetes mellitus.

Exclusion Criteria

The exclusion criteria are the presence of previous bilateral major limb amputation, or persons unable to consent, cognitive impairment, or experiencing a palliative medical condition, or persons that cannot attend minimum follow up of 12 months.

The withdrawal criteria is patient preference.

Study & Design

• Study Type: Observational
• Study Design: Not specified