Status:
UNKNOWN
Alprostadil as an Adjuvant Therapy With Indirect Angiosomal Revascularization in Critical Limb Ischemia.
Lead Sponsor:
Assiut University
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief 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 i...
Detailed Description
In large number of elderly patients aged between 50 and 75 years, the arterial disease is prevalent (1%-7%). It has a significant impact on the quality of life. Pain, fear of limb loss, increased inac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04312555
Start Date
April 1 2020
End Date
October 1 2021
Last Update
March 20 2020
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