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

Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection with Borderline Vascularity: an Important Consideration of Timing of Revascularization

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

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Limb Threatening Ischemia
• Intervention / Treatment: Other: PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY

Detailed 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

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Department of vascular surgery - Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ANGIOPLASTY GROUP; All patients undergoing PTA are going to be classified according to GLASS staging system	Other: PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY; SURGICAL DEBRIDEMNT; Other Names: REVASCULARIZATION
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; SURGICAL DEBRIDEMNT; Other Names: REVASCULARIZATION

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): November 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Ischemia; Foot Ulcer; Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Diabetic Foot
• Other Study ID Numbers: AST-KASH-ENDO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No