Toe Amputations in Patients With Diabetes

Diabetic Foot Clinical Trial

— PANDORAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05855980
• Other study ID #: R22101
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: December 2023
• Source: Tampere University Hospital
• Contact: Miska Vuorlaakso, PhD
• Phone: +3583311611
• Email: miska.vuorlaakso[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Amputation
• Diabetic Foot
• Infections

Intervention

Procedure:
• Wound closure
Wound is closed or left open to heal secondarily after amputation.

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healed	Percentage of patients with completely healed (no dehiscence, necrosis etc.) wound in 3 month control visit	3 months
Secondary	Complications	Percentage of patients experiencing complication during 3 month follow-up	3 months
Secondary	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
Secondary	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
Secondary	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