Inforatio Technique to Promote Wound Healing of Diabetic Foot Ulcers

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 definition of inforatio technique is application of small cuts in wound beds with punch biopsy tools without involving surrounding epithelia. The aim is to initiate an acute inflammatory response that will promote healing of the ulcers.

Conditions

• Diabetic Foot Ulcer
• Diabetes
• Foot Ulcer
• Diabetic Foot
• Diabetes Complications
• Diabetes Mellitus

Interventions

PROCEDURE

Inforatio technique

Inforatio technique is a novel minimal invasive procedure where small cuts are made on wound beds with punch biopsy tools near the wound edges but without involving wound edge epithelia. Inforatio technique is applied after the wound has been surgically debrided for slough and devitalized tissue.

OTHER

Usual care of the respective outpatient clinics

Usual care of the DFUs includes local wound care and offloading treatment.

Sponsors & Collaborators

• Steno Diabetes Center Sjaelland

  collaborator OTHER_GOV

• Zealand University Hospital

  lead OTHER

Principal Investigators

• Sahar Moeini, MD · Zealand University Hospital

• Hans Gottlieb, MD PhD · University of Copenhagen

• Tue S Jørgensen, MD PhD · Zealand University Hospital

• Thomas V Aagaard, PT MsC · Holbaek Hospital

• Maj R Kornø, MD · Nykoebing Falster Hospital

• Malene RB Larsen, MD · Zealand University Hospital

• Stig Brorson, MD PhD DMsc · Zealand University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-10

Primary Completion

2024-12-18

Completion

2025-08-14

Countries

• Denmark

Study Locations