Diabetic FootPANDORATNCT05855980
Toe Amputations in Patients With Diabetes
A study testing Wound closure in people with Diabetic Foot and Infections, run by Tampere University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Infections, Amputation
- What is being tested?
- Wound closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteFinland
- Study dates
- 22 May 2023to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Toe amputation due to diabetic foot infection
Who cannot join
- Deep foot infection
- Sepsis
- No clinical infection (amputation due to trauma, deformity or uninfected necrosis)
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Tampere University Hospital
Tampere
Miska Vuorlaakso, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Foot, Infections, Amputation
- Being tested
- Wound closure
- Keywords
- Diabetic foot, Infection, Amputation
- Medical subject headings
- Diabetic Foot, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound closureProcedure or surgery
Wound is closed or left open to heal secondarily after amputation.
| Study group | Role | What they receive |
|---|---|---|
| Closed wound | Active comparator | Wound is closer immediately after amputation (instead healing secondarily) Receives: Procedure: Wound closure |
| Open wound | No intervention | Wound is left to heal secondarily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healed
Percentage of patients with completely healed (no dehiscence, necrosis etc.) wound in 3 month control visit
Measured: 3 months
Secondary outcomes (4)
Complications
Percentage of patients experiencing complication during 3 month follow-up
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start22 May 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miska Vuorlaakso, Tampere University Hospital
- Investigators
- Miska Vuorlaakso, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855980
- Sponsor's protocol ID
- R22101
- Acronym
- PANDORAT
- Status last verified
- Dec 2023
- First submitted
- 5 Apr 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toe Amputations in Patients With Diabetes - the Effect of Leaving a Wound Open or Closing on Healing and Ambulation After Surgery.
- ClinicalTrials.gov ID
- NCT05855980
- Acronym / sponsor ID
- PANDORAT / R22101
- Conditions
- Diabetic Foot, Infections, Amputation
- Keywords
- Diabetic foot, Infection, Amputation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed wound | Active comparator | Procedure: Wound closureWound is closer immediately after amputation (instead healing secondarily) |
| Open wound | No intervention | –Wound is left to heal secondarily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Toe amputation due to diabetic foot infection
Key exclusion criteria (3 listed)
- Deep foot infection
- Sepsis
- No clinical infection (amputation due to trauma, deformity or uninfected necrosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wound closureWound is closed or left open to heal secondarily after amputation. | Procedure or surgery | Closed wound |
Primary outcome
Wound healed
Time frame: 3 months
Percentage of patients with completely healed (no dehiscence, necrosis etc.) wound in 3 month control visit
4 secondary outcomes
Complications
Time frame: 3 months
Functional outcome: 15D
Time frame: 3 months
Functional outcome: TESS
Time frame: 3 months
Functional outcome: FHSQ
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miska Vuorlaakso, PhD principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound closure in people with Diabetic Foot and Infections, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miska Vuorlaakso, PhD (+3583311611, miska.vuorlaakso@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healed (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023; AzTrials last refreshed its copy on 28 Oct 2026.