MedTrace Logo

Treatment of Diabetic Foot Ulcers With Inforatio Technique to Promote Wound Healing

NCT03985306 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-10-30

No results posted yet for this study

Summary

This trial will examine the feasibility of conducting a definitive randomized clinical trial that tests whether inforatio technique will reduce time to healing of diabetic foot ulcers. Inforatio technique is a procedure where small punch biopsies are taken from the wound bed near the edge of the wound. With this technique, the investigators wish to initiate an acute inflammatory response that increases the generation of granulation tissue with subsequent healing by scar formation. Thus, the investigators hypothesize that inforatio technique will promote healing of diabetic foot ulcers.

Based on clinical experience, the investigators have previously detected a reduction in time to healing as an unexpected effect when multiple punch biopsies are taken from the wound bed of diabetic foot ulcers. To the knowledge of the investigators, methods similar to the inforatio technique has not previously been studied.

Conditions

  • Diabetic Foot Ulcer
  • Diabetic Foot
  • Wound Heal
  • Ulcer Foot
  • Ulcer Healing

Interventions

PROCEDURE

Inforatio technique

We define the inforatio technique as punch biopsies taken in the periphery of the wound bed. The punch biopsies will have a diameter of two mms. The depth of the biopsies is primarily based on clinical assessment on distance to bone by assessment with a sterile wound probe and with attention to location and anatomy. The maximum depth will be 3.5 millimeters. The biopsies will be taken from one to two mms from the wound edges and with a distance of five mms between the biopsies. Inforatio technique is applied after standard care and wound assessment.

Sponsors & Collaborators

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Sahar Moeini, MD · Zealand University Hospital Koege, Denmark

  • Hans Gottlieb, Chief consultant, MD PhD · Herlev University Hospital, Denmark

  • Tue S Jørgensen, MD PhD · Hvidovre University Hospital, Denmark

  • Malene RB Larsen, MD · Zealand University Hospital Koege, Denmark

  • Stig Brorson, Professor, MD PhD DMsc · Zealand University Hospital Koege, Denmark

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-20
Primary Completion
2019-09-26
Completion
2019-09-26

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03985306 on ClinicalTrials.gov