NCT07554092 Comparison of Radiological Outcome of Conventional vs Accelerated Ponseti Casting Technique for Treatment of Club Foot
| NCT ID | NCT07554092 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Khyber Medical University Peshawar |
| Condition | Club Foot |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 144 participants in total. It began in 2026-02-01 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Club foot (congenital talipes equinovarus) is a common birth deformity affecting 1-2 per 1,000 live births, with even higher rates in low-income countries. The standard treatment is the Ponseti method using weekly serial casts, but weekly visits for several weeks can be challenging for families in hot climates or with limited resources. This randomized controlled trial compares the standard once-weekly Ponseti casting with an accelerated twice-weekly casting technique. The primary outcome is radiological correction measured by the lateral talocalcaneal angle (target ≥35°) on standardized foot X-rays taken six weeks after brace fitting. Secondary outcomes include the talocalcaneal index (\>40) and the tibio-calcaneal (dorsiflexion) angle (60-90°). Babies under six months of age with idiopathic club foot will be randomly assigned to either the standard or accelerated casting group. All other aspects of the Ponseti method (manipulation, number of casts, tenotomy when needed, final cast for three weeks, and foot abduction orthosis) remain identical. Adverse events such as skin problems, swelling, or cast complications will be recorded. The study aims to determine whether accelerated casting achieves better radiographic correction without increasing risks.
Eligibility Criteria
Inclusion Criteria: -Both gender with idiopathic club foot with age less than 6 months Exclusion Criteria: * Syndromic club foot (e.g., associated with arthrogryposis, myelomeningocele, or other genetic syndromes) * Previous treatment for club foot (either serial casting or surgical intervention) * Any other significant congenital anomaly or medical condition that, in the opinion of the investigator, would interfere with treatment or follow-up
Contact & Investigator
Sikandar Hayat, MBBS, FCPS (Orthopedic Surgery
PRINCIPAL INVESTIGATOR
Khyber Medical University Peshawar
Frequently Asked Questions
Who can join the NCT07554092 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 5 Months, studying Club Foot. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07554092 currently recruiting?
Yes, NCT07554092 is actively recruiting participants. Contact the research team at drsikandar68@gmail.com for enrollment information.
Where is the NCT07554092 trial being conducted?
This trial is being conducted at Peshawar, Pakistan.
Who is sponsoring the NCT07554092 clinical trial?
NCT07554092 is sponsored by Khyber Medical University Peshawar. The principal investigator is Sikandar Hayat, MBBS, FCPS (Orthopedic Surgery at Khyber Medical University Peshawar. The trial plans to enroll 144 participants.