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NCT Number: NCT05553509

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of vascular surgery - Assiut University Hospital

Asyut, Asyut Governorate, 71515, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY

Other

SURGICAL DEBRIDEMNT

Other names: REVASCULARIZATION

Primary outcomes

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

    Time frame: 1 YEAR

    • 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

Secondary outcomes

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

    Time frame: 1 YEAR

    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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 23, 2022
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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