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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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05553509
Enrollment
70
Registered
2022-09-23
Start date
2023-01-01
Completion date
2025-09-01
Last updated
2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Limb Threatening Ischemia

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

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

Interventions

OTHERPER CUTANEOUS TRANSLUMINAL ANGIOPLASTY

SURGICAL DEBRIDEMNT

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection With Borderline Vascularity1 YEAR1. 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

Secondary

MeasureTime frameDescription
Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection With Borderline Vascularity1 YEAR1-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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026