Alprostadil as an Adjuvant Therapy With Indirect Angiosomal Revascularization in Critical Limb Ischemia.

• Status: Not yet recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to assess the efficacy of Alprostadil (Prostaglandin E2) as adjuvant therapy after failure of direct but indirect angiosomal revascularization in patients with critical limb ischemia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: Alprostadil

Criteria

Inclusion Criteria:

• Subject ≥ 40 years.

• Subject with chronic limb ischemia [Rutherford classification 4, 5 & 6].

• Subject failed to direct revascularization.

• Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.

• Subject has provided written informed consent.

Exclusion Criteria:

• Subject's age less than 40.

• Imminent or foreseeable amputation

• Subject already had a major amputation on the affected extremity

• Subject has emergent ischemic lesion [such as gas forming infection].

• Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment.

• Subject has a known hypersensitivity or contraindication to Alprostadil.

• Subject is not in the position to be primarily revascularized or refuses surgery.

• Acute ischemia and peripheral vascular disorders of inflammatory or immunologic origin

• Neuropathic or venous ulcers

• Already using vasoactive medication or prostaglandins

• Treatment with prostanoids within 3 months prior to inclusion