Toe TransferNCT06487676
Long Term Follow up of Toe-to-hand Transfers
An observational study of Toe Transfer and Free Tissue Flap, run by Chang Gung Memorial Hospital.
Trial summary
Toe transfers are perceived to have changed the landscape of the injured hand over the last half century, yet there are limited validated data that unequivocally support the functional role of toe transfers after traumatic digital amputation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Toe Transfer, Free Tissue Flap, Patient Reported Outcome Measures
- What is being tested?
- Toe transfer and Replantation
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2015to 27 Oct 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients operated on by single surgeon (FCW) at Chang Gung Memorial Hospital from 1983 to 2015, with at least 5 years follow up at time of inclusion to study
Who may be able to join
- Toe transfers
- minimum 5 year follow up
Who cannot join
- partial toe transfers including toenail, toe pulp or vascularised joint
- under 5 year follow up
About this study
Official title: Long Term Follow up of Toe-to-hand Transfers: Validated Patient Reported Outcomes
Toe transfers are perceived to have changed the landscape of the injured hand over the last half century, yet there are limited validated data that unequivocally support the functional role of toe transfers after traumatic digital amputation. There also remain unanswered questions about what factors critically influence functional outcomes, be it sensory recovery, grip strength or other modality. Furthermore, the use of validated patient reported outcome measures (PROMs) in large series of toe transfers with long term follow up, is lacking.
Read the detailed description
Finger amputations are associated with profound impacts on physical, socio-economic, vocational and mental well-being. Thumb amputations account for the greatest burden of disability globally amongst hand trauma.
The multi-centre FRANCHISE study and a recent large prospective multi-centre study have demonstrated that finger replantation outperforms equivalent amputations in nearly all digits at all levels, except for the little finger. However, one crucial question in hand surgery is whether toe transfers can provide a similar functional benefit to replantation.
Finger amputations are frequently not replantable even with timely access to specialized reconstructive care. A review of replantation in the USA found that of 3,417 digital amputations, only 631 replantations were attempted (18%), and of these 30% failed. Therefore nearly 90% of patients with finger amputations will ultimately live without the amputated digit.
Microvascular toe-to-hand transfer, first described in the 1960s, has a success rate close to 100% in high volume centres. There are few validated data that support the functional benefits of toe transfer, with the majority of outcome studies focusing on operative survival rates, physical measurements such as grip strength, or employ unvalidated scales and self-created questionnaires. More data, in larger more representative populations, using validated PROMs, is required.
Here, we aim to demonstrate using PROMS that the role of toe transfers has equivalent or improved functional benefits, with comparison to finger replantation. Additionally, this study aims to identify physical factors that have the greatest influence on patient reported outcomes. This may answer fundamental questions regarding optimum strategies for the design of toe transfers.
- Being tested
- Toe transfer, Replantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toe transferProcedure or surgery
Toe-to-hand transfer
ReplantationProcedure or surgery
Also called Finger or thumb replantation
Finger or thumb replantation after amputation
| Study group | Role | What they receive |
|---|---|---|
| Toe transfer | Patients who have undergone toe to hand transfer Receives: Procedure: Toe transfer | |
| Replantation | Patients who have undergone finger replantation Receives: Procedure: Replantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Michigan Hand Questionnaire
Validated Hand function patient reported outcome measured. 0-100. Higher is better
Measured: Single time-point, on average 22 years after surgery
Secondary outcomes (3)
Short Form 36
Short Form 36 Quality of Life. 0-100. Higher is better
Measured: Single time-point, on average 22 years after surgery
Foot Function Index
Validated foot function Patient reported outcome measure. 0-100. Lower is better
Measured: Single time-point, on average 22 years after surgery
Aesthetic evaluation
Subjective evaluation of toe transfer appearance using a Visual Analogue Scale, not validated
Measured: Longitudinal. 3 timepoints: 1 day before surgery, 1 day after surgery, and on average 22 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start31 Jul 2015
- Primary completion27 Oct 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toe TransferStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fu Chan Wei, FACS, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487676
- Sponsor's protocol ID
- 201505775B0C104
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data subject to privacy and legal restrictions - not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow up of Toe-to-hand Transfers: Validated Patient Reported Outcomes
- ClinicalTrials.gov ID
- NCT06487676
- Acronym / sponsor ID
- 201505775B0C104
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 31 Jul 2015 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 5 Jul 2024 (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.
Toe transfers are perceived to have changed the landscape of the injured hand over the last half century, yet there are limited validated data that unequivocally support the functional role of toe transfers after traumatic digital amputation. There also remain unanswered questions about what factors critically influence functional outcomes, be it sensory recovery, grip strength or other modality. Furthermore, the use of validated patient reported outcome measures (PROMs) in large series of toe transfers with long term follow up, is lacking.
Detailed description
Finger amputations are associated with profound impacts on physical, socio-economic, vocational and mental well-being. Thumb amputations account for the greatest burden of disability globally amongst hand trauma.
The multi-centre FRANCHISE study and a recent large prospective multi-centre study have demonstrated that finger replantation outperforms equivalent amputations in nearly all digits at all levels, except for the little finger. However, one crucial question in hand surgery is whether toe transfers can provide a similar functional benefit to replantation.
Finger amputations are frequently not replantable even with timely access to specialized reconstructive care. A review of replantation in the USA found that of 3,417 digital amputations, only 631 replantations were attempted (18%), and of these 30% failed. Therefore nearly 90% of patients with finger amputations will ultimately live without the amputated digit.
Microvascular toe-to-hand transfer, first described in the 1960s, has a success rate close to 100% in high volume centres. There are few validated data that support the functional benefits of toe transfer, with the majority of outcome studies focusing on operative survival rates, physical measurements such as grip strength, or employ unvalidated scales and self-created questionnaires. More data, in larger more representative populations, using validated PROMs, is required.
Here, we aim to demonstrate using PROMS that the role of toe transfers has equivalent or improved functional benefits, with comparison to finger replantation. Additionally, this study aims to identify physical factors that have the greatest influence on patient reported outcomes. This may answer fundamental questions regarding optimum strategies for the design of toe transfers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toe transfer | – | Procedure: Toe transferPatients who have undergone toe to hand transfer |
| Replantation | – | Procedure: ReplantationPatients who have undergone finger replantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients operated on by single surgeon (FCW) at Chang Gung Memorial Hospital from 1983 to 2015, with at least 5 years follow up at time of inclusion to study
Key inclusion criteria (2 listed)
- Toe transfers
- minimum 5 year follow up
Key exclusion criteria (2 listed)
- partial toe transfers including toenail, toe pulp or vascularised joint
- under 5 year follow up
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 |
|---|---|---|
| Toe transferToe-to-hand transfer | Procedure or surgery | Toe transfer |
| ReplantationAlso: Finger or thumb replantationFinger or thumb replantation after amputation | Procedure or surgery | Replantation |
Primary outcome
Michigan Hand Questionnaire
Time frame: Single time-point, on average 22 years after surgery
Validated Hand function patient reported outcome measured. 0-100. Higher is better
3 secondary outcomes
Short Form 36
Time frame: Single time-point, on average 22 years after surgery
Foot Function Index
Time frame: Single time-point, on average 22 years after surgery
Aesthetic evaluation
Time frame: Longitudinal. 3 timepoints: 1 day before surgery, 1 day after surgery, and on average 22 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: Undecided. Data subject to privacy and legal restrictions - not yet decided
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.
Fu Chan Wei, FACS principal investigator
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Toe Transfer and Free Tissue Flap, run by Chang Gung Memorial Hospital.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Michigan Hand Questionnaire (time frame: Single time-point, on average 22 years after surgery). 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 5 Jul 2024.