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

Assiut University

Status: Active, not recruiting

Conditions: Chronic Limb Threatening Ischemia

Treatments: Other: PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY

Study type: Observational

Funder types: Other

Identifiers

NCT05553509

AST-KASH-ENDO

Details and patient eligibility

About

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

Full 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

Enrollment: 70 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

70 participants in 2 patient groups

ANGIOPLASTY GROUP

Description:

All patients undergoing PTA are going to be classified according to GLASS staging system

Treatment:

Other: PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY

DEBRIDEMENT GROUP

Description:

The most commonly used technique for diabetic foot ulcers is sharp or surgical debridement using a scalpel, tissue forceps or similar instruments. It should be sufficiently extensive to remove all infected and necrotic tissue;

Treatment:

Other: PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY