Treatment for congenital clubfoot using Saleem's protocol
Effect of Saleem's Protocol on Foot Deformity in Congenital Talipes Equinovarus
NA · Pakistan Society for Rehabilitation of Differently Abled Hospital · NCT05957627
This study is testing a new method for treating clubfoot in babies that uses a combination of surgery and casting to see if it can fix the foot deformity more effectively and with fewer casts.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 1 Month to 1 Year |
| Sex | All |
| Sponsor | Pakistan Society for Rehabilitation of Differently Abled Hospital (other) |
| Locations | 1 site (Lahore, Punjab) |
| Trial ID | NCT05957627 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Saleem's protocol, which combines early tenotomy and serial foot casting, for treating congenital idiopathic talipes equinovarus. The pilot study involved ten children under one year of age, assessing their foot deformity using the PIRANI scoring system before and after treatment. The aim is to achieve early correction of the deformity with minimal casts and no recurrence. The study addresses a common congenital condition that can lead to lifelong impairment if untreated.
Who should consider this trial
Good fit: Ideal candidates for this study are children under one year of age diagnosed with congenital idiopathic clubfoot.
Not a fit: Patients who may not benefit include those with neuropathy, syndromic clubfoot, previous Ponsetti treatment, foot drop, or those over one year of age.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for children with congenital clubfoot, leading to better long-term outcomes.
How similar studies have performed: While the combined approach of early tenotomy and serial casting has not been proven in prior investigations, this study aims to explore its effectiveness, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children with congenital idiopathic clubfoot * Both male and female under 1 year of age * Participiants who are willing to participate Exclusion Criteria: * Childrens who suffer from neuropathy * Childrens with syndromic club foot * Childrens have done ponsetti before * Childrens with foot drop * Above 1 year of age
Where this trial is running
Lahore, Punjab
- Pakistan Society for the Rehabilitation of Diffrently Abled Hospital — Lahore, Punjab, Pakistan (RECRUITING)
Study contacts
- Principal investigator: Nayab Iqbal, MS — PSRD
- Study coordinator: M Faheem Afzal, PHD
- Email: faheem78601@gmail.com
- Phone: 03336966697
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Talipes Equinovarus