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PANDORAT: Toe Amputations in Patients With Diabetes

Sponsor
Tampere University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05855980
Collaborator
(none)
102
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Wound closure
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Toe Amputations in Patients With Diabetes - the Effect of Leaving a Wound Open or Closing on Healing and Ambulation After Surgery.
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Wound healed [3 months]

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

Secondary Outcome Measures

  1. Complications [3 months]

    Percentage of patients experiencing complication during 3 month follow-up

  2. Functional outcome: 15D [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. Functional outcome: TESS [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.

  4. Functional outcome: FHSQ [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tampere University Hospital Tampere Finland

Sponsors and Collaborators

  • Tampere University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Miska Vuorlaakso, Principal Investigator, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT05855980
Other Study ID Numbers:
  • R22101
First Posted:
May 12, 2023
Last Update Posted:
May 12, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Miska Vuorlaakso, Principal Investigator, Tampere University Hospital
Diabetic foot
Infection
Amputation
Additional relevant MeSH terms:
Diabetic Foot

Study Results

No Results Posted as of May 12, 2023