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Toe Amputations in Patients With Diabetes (PANDORAT)

Primary Purpose

Diabetic Foot, Infections, Amputation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Wound closure
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring Diabetic foot, Infection, Amputation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Tampere University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Closed wound

Open wound

Arm Description

Wound is closer immediately after amputation (instead healing secondarily)

Wound is left to heal secondarily

Outcomes

Primary Outcome Measures

Wound healed
Percentage of patients with completely healed (no dehiscence, necrosis etc.) wound in 3 month control visit

Secondary Outcome Measures

Complications
Percentage of patients experiencing complication during 3 month follow-up
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.
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.
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.

Full Information

First Posted
April 5, 2023
Last Updated
May 3, 2023
Sponsor
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05855980
Brief Title
Toe Amputations in Patients With Diabetes
Acronym
PANDORAT
Official Title
Toe Amputations in Patients With Diabetes - the Effect of Leaving a Wound Open or Closing on Healing and Ambulation After Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Infections, Amputation
Keywords
Diabetic foot, Infection, Amputation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Closed wound
Arm Type
Active Comparator
Arm Description
Wound is closer immediately after amputation (instead healing secondarily)
Arm Title
Open wound
Arm Type
No Intervention
Arm Description
Wound is left to heal secondarily
Intervention Type
Procedure
Intervention Name(s)
Wound closure
Intervention Description
Wound is closed or left open to heal secondarily after amputation.
Primary Outcome Measure Information:
Title
Wound healed
Description
Percentage of patients with completely healed (no dehiscence, necrosis etc.) wound in 3 month control visit
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Complications
Description
Percentage of patients experiencing complication during 3 month follow-up
Time Frame
3 months
Title
Functional outcome: 15D
Description
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.
Time Frame
3 months
Title
Functional outcome: TESS
Description
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.
Time Frame
3 months
Title
Functional outcome: FHSQ
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miska Vuorlaakso, PhD
Phone
+3583311611
Email
miska.vuorlaakso@gmail.com
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miska Vuorlaakso, PhD

12. IPD Sharing Statement

Learn more about this trial

Toe Amputations in Patients With Diabetes

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