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

NCT ID: NCT05553509

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-09-01

Brief Summary

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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

Detailed Description

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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

Conditions

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Chronic Limb Threatening Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ANGIOPLASTY GROUP

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

PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY

Intervention Type OTHER

SURGICAL DEBRIDEMNT

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;

PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY

Intervention Type OTHER

SURGICAL DEBRIDEMNT

Interventions

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PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY

SURGICAL DEBRIDEMNT

Intervention Type OTHER

Other Intervention Names

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REVASCULARIZATION

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Kareem Ayman Hussien Shaamash

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of vascular surgery - Assiut University Hospital

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AST-KASH-ENDO

Identifier Type: -

Identifier Source: org_study_id

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