Timing of Revascularization in Patients With Diabetic Foot Ulcer and Non-critical Peripheral Artery Disease

NCT04939038 | Terminated DMC

• 1 other identifier: 1495 DIFU
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief Summary

This study investigates whether, compared to standard treatment, immediate restoration of blood flow (revascularization) can reduce complications and improve diabetic foot ulcer healing.

Conditions

Diabetic Foot Ulcer

Keywords

Revascularization; Lower extremity arterial disease; Non-critical peripheral artery disease

Outcome Measures

Primary Outcomes (6)

• Number of patients with cardiovascular death

  up to 12 months

• Number of patients with non-fatal myocardial infarction or all-cause stroke

  up to 12 months after randomization

• Number of patients with major amputation

  up to 12 months after randomization

• Number of patients with Minor amputation

  up to 12 months after randomization

• Number of patients with missed diabetic foot ulcer healing

  i.e. Incomplete epithelization of the index ulcer at 90 days

  90 days after randomization

• Number of patients with delayed diabetic foot ulcer healing

  Reduction of wound size of less than 50% at 45 days

  45 days after randomization

Secondary Outcomes (7)

• Number of patients with new ulcer of the index foot

  up to 12 months after randomization

• Number of patients with all clinically-driven revascularizations at the index limb

  up to 12 months after randomization

• Each component of the primary outcome individually

  up to 12 months after randomization

• Number of in-hospital days and costs

  up to 12 months after randomization

• Change in quality of life (QoL) assessed by the Cardiff Wound Impact Schedule questionnaire

  from baseline to 90 days and 12 months after randomization

Other Outcomes (8)

• Infection of the index ulcer

  up to 12 months after randomization

• Severity of infection

  up to 12 months after randomization

• Index diabetic foot ulcer healing time

  up to 12 months after randomization

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Standard wound care for diabetic wound ulcer

Procedure: Standard wound care

Immediate revascularization

EXPERIMENTAL

Patient will have revascularization 0 - 7 days after initial wound assessment and then receive standard wound care for diabetic wound ulcer

Procedure: Revascularization; Procedure: Standard wound care

Interventions

Revascularization PROCEDURE

Depending on the condition of the patients, patients will have either endovascular or surgical revascularization

Immediate revascularization

Standard wound care PROCEDURE

Standard wound care according to guidelines

Control Arm; Immediate revascularization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent as documented by signature
• Patients that are at least 18 years old
• Patients that have at least one DFU(s) of ≥ 0.2 cm2 and ≤ 10 cm2 as assessed by the ruler method multiplying the greatest length and width of the ulcer after debridement to determine the surface area. The largest eligible ulcer (≤ 10 cm2) will be defined as index ulcer and the corresponding extremity as index limb (in case of multiple equally sized ulcers the following rules will apply: If on different feet, the dominant side and if on the same foot, the more peripheral one will be the index ulcer)
• Patients that have non-critical LEAD of the index leg, defined by a single non-invasive examination at screening:
• Ankle brachial index (ABI) ≥ 0.5 and ≤ 0.9 AND absolute ankle pressure ≥ 50 mmHg OR
• ABI \> 0.9 OR incompressible ankle pressures AND toe brachial index (TBI) ≤ 0.7 AND absolute toe pressure ≥ 30 mmHg
• Patients on medical treatment for glycemic control with diagnosis of diabetes mellitus that was assessed by criteria as recommended by the guideline 2019 "ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD". Or patient without medical treatment but diagnosed with diabetes mellitus via HbA1c.
• Patients with life expectancy \> 12 months and without any disabilities due to end-stage cancer, heart failure, severe chronic obstructive pulmonary disease (COPD), or dementia

You may not qualify if:

• Critical limb ischemia of the index leg defined as ABI ≤ 0.4 (or absolute ankle pressure \< 50 mmHg)
• Need for major amputation
• Severe infection at the index foot according to IDSA classification
• Patient refuses minor amputation despite strong recommendation due to severe infection, necrosis or osteomyelitis at screening assessment
• Any revascularization procedure at the index leg within 3 months before randomization
• Positive urine or blood pregnancy test result, breast feeding or intention to become pregnant
• Non-compliance for any reason to procedures or study assessments (e.g. due to cognitive impairment or geographic distance)
• Participation in another drug study within the 30 days preceding or during the present study
• Untreated known antiphospholipid antibody syndrome and polycythaemia vera
• Known significant bleeding risk, or known coagulation disorder (INR \> 3.0 and platelet count \< 30,000/mm3) without any option to correct within 7 calendar days after initial wound assessment

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator
• Swiss National Science Foundation: collaborator

Study Sites (4)

Clinic for Angiology, University of Basel

Basel, Switzerland

Location

University Clinic for Angiology, University Hospital Inselspital, Berne

Bern, 3010, Switzerland

Location

Angiologie, Luzerner Kantonsspital

Lucerne, Switzerland

Location

Clinic for Vascular Surgery, Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Prof. Dr. med. Iris Baumgartner

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: June 25, 2021
• Study Start: January 25, 2022
• Primary Completion: September 18, 2024
• Study Completion: September 18, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)