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

NCT05553509 | Active Not Recruiting

• 1 other identifier: AST-KASH-ENDO
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Limb Threatening Ischemia

Outcome Measures

Primary Outcomes (1)

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

  1. Observe the timing to complete wound healing in both cohorts those with Debridement only \& those with Debridment plus PTA 2. Observe the Rate of limb salvage in both groups

  1 YEAR

Secondary Outcomes (1)

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

  1 YEAR

Study Arms (2)

ANGIOPLASTY GROUP

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

Other: PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY

DEBRIDEMENT GROUP

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;

Other: PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY

Interventions

PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY OTHER

SURGICAL DEBRIDEMNT

Also known as: REVASCULARIZATION

ANGIOPLASTY GROUP; DEBRIDEMENT GROUP

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

On the other hand we can consider patients as Borderline ischemia/ Boarderline Vascularity with (Rutherford Grade "I" Categories "2\&3) when they have a borderline ankle systolic pressure

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Department of vascular surgery - Assiut University Hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 23, 2022
• Study Start: January 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: September 1, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)