The comparison in development of wound bed granulation of topical oxygen therapy during negative pressure wound therapy to conventional negative pressure wound therapy in successful ischemic wound revascularized patients; A Randomized Clinical Trial.

Phase 4

Recruiting

• Conditions: Chronic limb threatening ischemia and ischemic wound; Negative pressure wound therapy; Topical oxygen therapy; Ischemic foot ulcer; Chronic limb threatening ischemia; Revascularization; Granulation tissue

• Registration Number: TCTR20230504001
• Lead Sponsor: Rajavithi Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-04
• Last Update Posted: 19 August 2024
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Patients were diagnosed Chronic limb threatening ischemia with ischemic foot ulcer
2.Successful below knee revascularization at least 2 of 3 vessels such as anterior tibial artery , posterior tibial artery, pernoneal artery.
3. Age more than 18 years old
4. Pre-treatment serum albumin more than 3 gram/d

Exclusion Criteria

1. Patients do not have contraindication for endovascular revascularization
2. Unsuccessful revascularized patients or successful revascularization only 1 of 3 vessels.
3. Patients who was performed a major amputation (ex. below knee amputation or above knee amputation) of index limb.
4. Patients with combined chronic arterial and venous insufficiency.
5. Patients who is taking the steriod drugs, immunosuppressive drugs or antineoplastic drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to complete wound granulation tissue at the time wound bed is filled with granulation tissue full wound bed granulation tissue