Metformin for treating peripheral artery disease-related walking impairment

Phase 4

Recruiting

• Conditions: Peripheral Artery Disease; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12618001186246
• Lead Sponsor: James Cook University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-17
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. PAD diagnosed by a vascular specialist based on current guidelines including PAD symptoms and absence of lower limb pulses or resting ABPI <0.9 or >1.4, or imaging evidence of lower limb arterial stenosis or occlusion;

2. Able to walk independently, with or without walking aids, but walking limited by intermittent claudication based on history and assessment by experienced observer during a six minute walk test;

3. No currently planned peripheral vascular intervention;

4. No contraindications to metformin, including renal impairment (defined as estimated glomerular filtration rate <45ml/min/1.73m2) and severe heart failure requiring in-patient treatment within the last 12 months or leading to shortness of breath at rest.

Exclusion Criteria

1. Asymptomatic PAD;
2. Patients currently involved in an exercise program for treating PAD;
3. Patients with severe PAD, such as rest pain or gangrene requiring urgent vascular intervention;
4. Previous major lower limb amputation;
5. Diabetes defined by Haemoglobin A1C (HbA1c) equal or greater than 6.5%.
6. Terminal illness making it unlikely the patient will survive 6 months;
7. Involvement in any other drug trial;
8. Clinical concern from the treating physician that the patient is not suitable for the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified