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Amputation, TraumaticNCT04192084

Microvascular Partial Toe Transfer

A study testing microvascular partial toe transfer in people with Amputation, Traumatic and Hand Injuries, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Microvascular partial toe transfer for reconstruction of traumatic amputation of the digits Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Amputation, Traumatic, Hand Injuries
What is being tested?
microvascular partial toe transfer
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
1 Dec 2019to 1 Dec 2020
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 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patient from 18-50 years old
  • one or more finger amputations
  • Minimum follow-up period of 6 months

Who cannot join

  • patients whose loss was due to congenital anomaly.
  • Patients who did not have a minimum follow-up period of six months .

About this study

Official title: Microvascular Partial Toe Transfer for Reconstruction of Traumatic Amputations of the Digits

Microvascular partial toe transfer for reconstruction of traumatic amputation of the digits

Read the detailed description

Microsurgical toe transfer has become a gold standard option for amputated digit reconstruction. It can be used to correct almost any thumb defect. However, for optimal functional and esthetic results, proper initial care, preoperative planning, proper selection of suitable techniques, adjunct or secondary procedures and proper, postoperative rehabilitation are important.

The transfer of a toe to replace an amputated thumb represents one of the first applications of microsurgical techniques, yet to this day remains an epitome of reconstructive surgery, restoring critical function and form to the hand-injured patient. While techniques have greatly evolved to permit the treatment of multiple finger amputations, dystrophic nails and pulps, and traumatized or arthritic joint, the amputated thumb retains its status among the most indubitable indications for toe transfer. Microsurgical techniques have been refined to such a degree that almost any ablative deformity of the thumb could be corrected with some form of toe transfer. The question, therefore, is not if a defect could be reconstructed, but whether the patient is willing to undergo reconstruction. The concepts of "adequate function" and "optimal function" are therefore of central importance when discussing treatment options with a patient. Obviously, these parameters will be different for each patient depending upon his/her vocation, avocations, and desires. For many people, adequate function might be expected with an amputation that retains some length of the proximal phalanx (assuming sufficient soft tissue coverage is present or can be provided). However, for patients who require full length of their thumb, or who desire optimal rather than adequate function, toe transfer should be considered.

At present, the decision to use a particular toe transfer technique is mostly based on the surgeon's preference and training. The current data are inadequate to make any comments with regards to donor site morbidity. Till such data are available, an evidence-based recommendation for the superiority of a specific type of toe-to-thumb transfer cannot be made. We hypothesis that partial toe transfer provides the best aesthetic and functional reconstruction and the least donor site morbidity amongst all other types of transfers.

Being tested
microvascular partial toe transfer
Medical subject headings
Amputation, Traumatic, Hand Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • microvascular partial toe transferProcedure or surgery

    we will perform microvascular partial toe transfer for patients with traumatic amputation of one or more digits

Study groups in NCT04192084
Study groupRoleWhat they receive
Traumatic amputations of the digitsExperimentalwe will perform microvascular partial toe transfer for patients with traumatic amputations of one or more digits
Receives: Procedure: microvascular partial toe transfer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. short-term functional outcome

    Using DASH (The Disabilities of the Arm, Shoulder and Hand) score Reference for Score: Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG) Am J Ind Med. 1996 Jun;29(6):602-8. Erratum in: Am J Ind Med 1996 Sep;30(3):372.

    The Institute for Work \& Health are the copyright owners of the DASH and QuickDASH Outcome Measures (http://www.dash.iwh.on.ca/)

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2019
  2. Study start1 Dec 2019 (estimated)
  3. Primary completion1 Nov 2020 (estimated)
  4. Study completion1 Dec 2020 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04192084
Sponsor's protocol ID
Toe Transfer
Status last verified
Dec 2019
First submitted
29 Nov 2019
Last updated
10 Dec 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Buncke HJ Jr, Buncke CM, Schulz WP. Immediate Nicoladoni procedure in the Rhesus monkey, or hallux-to-hand transplantation, utilising microminiature vascular anastomoses. Br J Plast Surg. 1966 Oct;19(4):332-7. doi: 10.1016/s0007-1226(66)80075-9. No abstract available.

    PubMed 4959061

  • Cobbett JR. Free digital transfer. Report of a case of transfer of a great toe to replace an amputated thumb. J Bone Joint Surg Br. 1969 Nov;51(4):677-9. No abstract available.

    PubMed 5371970

  • Wei FC, Chen HC, Chuang CC, Noordhoff MS. Simultaneous multiple toe transfers in hand reconstruction. Plast Reconstr Surg. 1988 Mar;81(3):366-77. doi: 10.1097/00006534-198803000-00009.

    PubMed 3340671

  • Wei FC, Lutz BS, Cheng SL, Chuang DC. Reconstruction of bilateral metacarpal hands with multiple-toe transplantations. Plast Reconstr Surg. 1999 Nov;104(6):1698-704. doi: 10.1097/00006534-199911000-00013.

    PubMed 10541171

  • Koshima I, Soeda S, Takase T, Yamasaki M. Free vascularized nail grafts. J Hand Surg Am. 1988 Jan;13(1):29-32. doi: 10.1016/0363-5023(88)90194-3.

    PubMed 3351225

  • Logan A, Elliot D, Foucher G. Free toe pulp transfer to restore traumatic digital pulp loss. Br J Plast Surg. 1985 Oct;38(4):497-500. doi: 10.1016/0007-1226(85)90007-4.

    PubMed 4052709

  • Wei FC, Chen HC, Chuang DC, Chen S, Noordhoff MS. Second toe wrap-around flap. Plast Reconstr Surg. 1991 Nov;88(5):837-43. doi: 10.1097/00006534-199111000-00016.

    PubMed 1924570

  • Chen SH, Wei FC, Chen HC, Hentz VR, Chuang DC, Yeh MC. Vascularized toe joint transfer to the hand. Plast Reconstr Surg. 1996 Dec;98(7):1275-84. doi: 10.1097/00006534-199612000-00025.

    PubMed 8942916

  • Lutz BS, Wei FC. Basic principles on toe-to-hand transplantation. Chang Gung Med J. 2002 Sep;25(9):568-76.

    PubMed 12479617

  • Lin PY, Sebastin SJ, Ono S, Bellfi LT, Chang KW, Chung KC. A systematic review of outcomes of toe-to-thumb transfers for isolated traumatic thumb amputation. Hand (N Y). 2011 Sep;6(3):235-43. doi: 10.1007/s11552-011-9340-x. Epub 2011 May 26.

    PubMed 22942845

  • Wei FC. Tissue preservation in hand injury: the first step to toe-to-hand transplantation. Plast Reconstr Surg. 1998 Dec;102(7):2497-501. doi: 10.1097/00006534-199812000-00039.

    PubMed 9858192

  • Yim KK, Wei FC. Intraosseous wiring in toe-to-hand transplantation. Ann Plast Surg. 1995 Jul;35(1):66-9. doi: 10.1097/00000637-199507000-00013.

    PubMed 7574290

  • Wilson CS, Buncke HJ, Alpert BS, Gordon L. Composite metacarpophalangeal joint reconstruction in great toe-to-hand free tissue transfers. J Hand Surg Am. 1984 Sep;9(5):645-9. doi: 10.1016/s0363-5023(84)80004-0.

    PubMed 6386954

  • Morrison WA, O'Brien BM, MacLeod AM. Thumb reconstruction with a free neurovascular wrap-around flap from the big toe. J Hand Surg Am. 1980 Nov;5(6):575-83. doi: 10.1016/s0363-5023(80)80110-9.

    PubMed 7000885

  • Wei FC, Chen HC, Chuang DC, Jeng SF, Lin CH. Aesthetic refinements in toe-to-hand transfer surgery. Plast Reconstr Surg. 1996 Sep;98(3):485-90. doi: 10.1097/00006534-199609000-00019.

    PubMed 8700986

Questions about this trial

What is this clinical trial studying?

A study testing microvascular partial toe transfer in people with Amputation, Traumatic and Hand Injuries, run by Assiut University.

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 3 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: status not confirmed, as of the sponsor's last update on 10 Dec 2019. 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?

Results are not available in the source record.

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?

short-term functional outcome (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04192084, which also lists 15 linked publications.

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 10 Dec 2019.

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