NCT07473908

Brief Summary

This study aims to assess the distance between the Achilles tendon and nearby neurovascular bundles bilaterally in infants with unilateral clubfoot deformity using ultrasound (US)- Doppler at 1 cm and 2 cm above the calcaneal tuberosity.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
18mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
May 2026Dec 2027

First Submitted

Initial submission to the registry

March 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

March 11, 2026

Last Update Submit

March 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • To measure the distance between the Achilles tendon and: • The posterior tibial neurovascular bundle In the clubfoot vs the normal foot

    baseline

Study Arms (2)

clubfoot

Device: ultrasound

normal foot

Device: ultrasound

Interventions

This study aims to assess the distance between the Achilles tendon and nearby neurovascular bundles bilaterally in infants with unilateral clubfoot deformity using ultrasound (US)- Doppler at 1 cm and 2 cm above the calcaneal tuberosity.

clubfootnormal foot

Eligibility Criteria

Age1 Month - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Thestudy population will consist of infants aged 1 to 12 months diagnosed with unilateral idiopathic clubfoot who present to the Orthopedic and Trauma Surgery Department at Assiut University Hospitals. Each participant will have one affected (clubfoot) limb and one normal contralateral foot, allowing for within-subject comparative measurements. Only infants with idiopathic, non-syndromic clubfoot deformity will be included to ensure homogeneity of the study group. Participants must have no history of previous foot surgery, no contralateral deformities, and no contraindications to ultrasound assessment. Parents or legal guardians of eligible infants will receive a full explanation of the study purpose and procedures prior to enrollment. Participation will be voluntary and based on written informed consent. A total sample of 40 infants (40 affected feet and 40 contralateral normal feet) will be recruited as a pilot population for measurement and comparison of Achilles tendon-neurovascula

You may qualify if:

  • Infants aged 1-6 months
  • Unilateral clubfoot deformity and a normal opposite foot

You may not qualify if:

  • Non-idiopathic or syndromic clubfoot
  • Previous foot surgery , contralateral foot deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Gutierrez Carbonell P, Navarro Amoros M, Ojeda Pena M, Pellicer Garcia V, Moril Penalver L. Ultrasound (US) measurement of the distance between the Achilles tendon and the posterior tibial neurovascular bundle in equinus infantile deformity. Skeletal Radiol. 2014 Jun;43(6):801-4. doi: 10.1007/s00256-014-1847-0. Epub 2014 Mar 13.

  • Hootnick DR, Packard DS Jr, Levinsohn EM. Necrosis leading to amputation following clubfoot surgery. Foot Ankle. 1990 Jun;10(6):312-6. doi: 10.1177/107110079001000605.

  • Dobbs MB, Gordon JE, Walton T, Schoenecker PL. Bleeding complications following percutaneous tendoachilles tenotomy in the treatment of clubfoot deformity. J Pediatr Orthop. 2004 Jul-Aug;24(4):353-7. doi: 10.1097/00004694-200407000-00002.

  • Jaszberenyi Z, Moriggi L, Schmidt P, Weidensteiner C, Kneuer R, Merbach AE, Helm L, Toth E. Physicochemical and MRI characterization of Gd3+-loaded polyamidoamine and hyperbranched dendrimers. J Biol Inorg Chem. 2007 Mar;12(3):406-20. doi: 10.1007/s00775-006-0197-3. Epub 2007 Jan 10.

  • Burghardt RD, Herzenberg JE, Ranade A. Pseudoaneurysm after Ponseti percutaneous Achilles tenotomy: a case report. J Pediatr Orthop. 2008 Apr-May;28(3):366-9. doi: 10.1097/BPO.0b013e3181653b6f.

  • Parada SA, Baird GO, Auffant RA, Tompkins BJ, Caskey PM. Safety of percutaneous tendoachilles tenotomy performed under general anesthesia on infants with idiopathic clubfoot. J Pediatr Orthop. 2009 Dec;29(8):916-9. doi: 10.1097/BPO.0b013e3181c18ab5.

  • Dogan A, Kalender AM, Seramet E, Uslu M, Sebik A. Mini-open technique for the achilles tenotomy in correction of idiopathic clubfoot: a report of 25 cases. J Am Podiatr Med Assoc. 2008 Sep-Oct;98(5):414-7. doi: 10.7547/0980414.

MeSH Terms

Conditions

Clubfoot

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Mahmoud samir dahesh

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03