Toe Amputations in Patients With Diabetes (PANDORAT)

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: Infections; Diabetic Foot; Amputation
• Intervention / Treatment: Procedure: Wound closure

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

• Study Contact: Name: Miska Vuorlaakso, PhD; Phone Number: +3583311611; Email: miska.vuorlaakso@gmail.com

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	Percentage of patients experiencing complication during 3 month follow-up	3 months
Functional outcome: 15D	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	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	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

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

Study record dates

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: Infection; Diabetic foot; Amputation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• 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