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

Study Overview
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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

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

Conditions
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Chronic Limb Threatening Ischemia

Intervention / Treatment
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* Other: PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ANGIOPLASTY GROUP<br>All patients undergoing PTA are going to be classified according to GLASS staging system | Other: PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY<br>* SURGICAL DEBRIDEMNT<br>* Other names: REVASCULARIZATION;|
| DEBRIDEMENT GROUP<br>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<br>* SURGICAL DEBRIDEMNT<br>* Other names: REVASCULARIZATION;|

What is the study measuring?
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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 |