Toe Amputations in Patients With Diabetes (PANDORAT)

December 5, 2023 updated by: Miska Vuorlaakso, Tampere University Hospital

Toe Amputations in Patients With Diabetes - the Effect of Leaving a Wound Open or Closing on Healing and Ambulation After Surgery.

This study is a randomized controlled trial (RCT) to evaluate outcome after toe amputation due to diabetic foot infection. Aim of this RCT is to evaluate wound healing and functional outcome based, whether wound is closed or left open. As a part of this study, emerging technology of thermal imaging is evaluated as a possible tool to predict complication after amputation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with diabetes undergoing toe amputation due to infection, are recruited for this study. Based on randomization, wound is either closed or left open during the amputation procedure. If primary closure is not possible (e.g. deep abscess) and patient is randomized to closed group, delayed closure is performed when feasible. Patients are followed up in outpatient clinic 3 month after amputation. Primary outcome is wound healing that is evaluated during follow ups in the outpatient clinic. Functional outcome is evaluated with PROM questionnaires preoperatively and during the follow up.

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
      • Tampere, Finland
        • Recruiting
        • Tampere University Hospital
        • Contact:
          • Miska Vuorlaakso, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Toe amputation due to diabetic foot infection

Exclusion Criteria:

  • Deep foot infection
  • Sepsis
  • No clinical infection (amputation due to trauma, deformity or uninfected necrosis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Closed wound
Wound is closer immediately after amputation (instead healing secondarily)
Procedure: Wound closure
Wound is closed or left open to heal secondarily after amputation.
No Intervention: Open wound
Wound is left to heal secondarily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound healed
Time Frame: 3 months
Percentage of patients with completely healed (no dehiscence, necrosis etc.) wound in 3 month control visit
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 3 months
Percentage of patients experiencing complication during 3 month follow-up
3 months
Functional outcome: 15D
Time Frame: 3 months

15D quality of life questionnaire 3 months after amputation and change compared to preoperative 15D score.

15D is 15 dimensional questionnaire that provides score between 0 and 1 representing health related quality of life (HRQOL). Higher value represents better HRQOL.
3 months
Functional outcome: TESS
Time Frame: 3 months

Toronto extremity salvage score (TESS) questionnaire 3 months after amputation and change compared to preoperative TESS score.

TESS is contains 30 questions (rated 1-5) measuring activity limitations. TESS result is a percentage of the maximum score, 100 representing normal activity.
3 months
Functional outcome: FHSQ
Time Frame: 3 months

Foot health status questionnaire (FHSQ) 3 months after amputation and change compared to preoperative FHSQ score.

FHSQ consists of 19 questions that ultimately provide score 0-100 higher value representing better foot health status.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Investigators

  • Principal Investigator: Miska Vuorlaakso, PhD, Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R22101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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