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Status:

ACTIVE_NOT_RECRUITING

Inforatio Technique to Promote Wound Healing of Diabetic Foot Ulcers

Lead Sponsor:

Zealand University Hospital

Collaborating Sponsors:

Steno Diabetes Center Sjaelland

Conditions:

Diabetic Foot Ulcer

Diabetes

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This randomized clinical trial will examine the effect of inforatio technique on healing of diabetic foot ulcers (DFUs). Inforatio technique is a novel procedure developed by the research group. The ...

Detailed Description

BACKGROUND 15-25% of diabetic patients develop chronic foot ulcers - a serious comorbidity that widely affects quality of life and is associated with increased mortality and morbidity. 50-60% of DFUs...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA
  • Age ≥ 18 years
  • Diabetes mellitus
  • Non-surgical ulcer located distal to the malleoli
  • Wound diameter \>4 millimeters
  • Patient-reported wound duration ≥ 6 weeks
  • Only one ulcer will be included from each participant. If a patient has more than one eligible ulcer, the largest ulcer is included. In case of equally sized ulcers, the ulcer with the most recent onset is included.
  • EXCLUSION CRITERIA
  • Dementia or other reasons that cause inability to give informed consent
  • Malignant disease
  • Current treatment with systemic immunosuppressive drugs.
  • Exclusion criteria related to the index extremity:
  • Diagnosed with or awaiting evaluation of suspected acute phase Charcot arthropathy or osteomyelitis
  • Non-palpable pulse in both arteria dorsalis pedis and arteria tibialis posterior accompanied by systolic toe pressure \<30 mmHg in the index foot.
  • Amputation at midfoot level or proximal to midfoot level
  • Revascularization procedure awaits or has been undertaken within the last 8 weeks or the patient awaits a vascular surgeons' decision on revascularization
  • Gangrene
  • Exclusion criteria related to the index ulcer
  • Infection of the ulcer defined according to IWGDF/IDSA (International Working Group on the Diabetic Foot/ Infectious Diseases Society of America system) classification as presence of at least 2 of the following; 1) local swelling or induration; 2) erythema \>0.5 to ≤2 cm around the ulcer; 3) local tenderness or pain; 4) local warmth; or 5) purulent discharge. Current antibiotic treatment due to infection of the index ulcer will also be considered as an ongoing infection regardless of presence of clinical signs of infection.
  • Positive probe-to-bone test
  • Exposed joint or tendon
  • The soft tissue layer covering bone or joint is evaluated to be too thin to allow for inforatio technique anywhere in the wound bed.
  • Interdigital ulcer location

Exclusion

    Key Trial Info

    Start Date :

    March 10 2022

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    February 1 2025

    Estimated Enrollment :

    100 Patients enrolled

    Trial Details

    Trial ID

    NCT05189470

    Start Date

    March 10 2022

    End Date

    February 1 2025

    Last Update

    August 16 2024

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Herlev University Hospital, Department of Orthopaedic Surgery

    Herlev, Denmark, 2730

    2

    Zealand University Hospital, Department of Orthopaedic Surgery

    Køge, Denmark, 4600

    3

    Nykoebing Falster Hospital

    Nykøbing Falster, Denmark, 4800

    4

    Slagelse Hospital, Department of Orthopaedic Surgery

    Slagelse, Denmark, 4200