Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection With Borderline Vascularity

Chronic Limb Threatening Ischemia Clinical Trial

Official title:

Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection With Borderline Vascularity: An Important Consideration Of Timing Of Revascularization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05553509
• Other study ID #: AST-KASH-ENDO
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: Kareem Shaamash
• Phone: 00201067838388
• Email: Kareemshaamash[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observe Timing to complete healing of wounds & Limb salvage in both cohorts those who are undergoing Debridement only and those who are undergoing Debridement plus PTA

Description:

Secondary Aims of the study include Length of hospital stay , Necessity of further intervention(Whether a Revascularization Procedure or More Debridement sessions) , Incidence of MACE (Major Adverse Cardiovascular Events) in both groups

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Patients will be included in this study are those suffering from DFUs; and Borderline Ischemia (BLI) / Borderline Vacularity with (Rutherford Grade "I" Categories "2&3") when they have a borderline ankle systolic pressure

Exclusion Criteria:

• All patients with (CLI) and DFUs as they are indicated for urgent re-vascularization.

Severely infected/ gangrenous wounds requiring amputation hindering possible limb salvage.

Lesions lying within or adjacent to an aneurysm; Non diabetic cases with foot ulcers; Arteritic lesions;(Vasculitic Patients). Patients had prior major amputation, bypass surgery, and endarterectomy on any vessel of the ipsilateral (target) extremity

Related Conditions & MeSH terms

• Chronic Limb Threatening Ischemia
• Chronic Limb-Threatening Ischemia
• Diabetic Foot
• Ischemia

Intervention

Other:
• PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY
SURGICAL DEBRIDEMNT

Locations

Country	Name	City	State
Egypt	Department of vascular surgery - Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection With Borderline Vascularity	Observe the timing to complete wound healing in both cohorts those with Debridement only & those with Debridment plus PTA; Observe the Rate of limb salvage in both groups	1 YEAR
Secondary	Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection With Borderline Vascularity	1-Observe incidence of MACE In both cohorts Observe necessity for further interventions in both cohorts 3-Observe the length of hospital stay in both groups	1 YEAR