Clubfoot DNA Repository

Status Completed

Clinical Trial Summary

To build a DNA repository to enable participation in ongoing and future Clubfoot genetic linkage studies.

Clinical Trial Description

Clubfoot is a birth defect that can occur alone (in isolation) or as a part of a disease like cerebral palsy (CP). Genetic linkage is a research tool in which DNA samples are tested for genetic landmarks (markers) whose location on chromosomes is known. Genes and markers that are physically close to one another on the chromosome are said to be tightly linked than genes and markers that are located far apart. This gives clues of where to search for genes causing isolated clubfoot. If there appears to be a high correlation between family members' inheritance of a particular marker, and their inheritance of the trait being studied (in this case clubfoot), the area of the chromosome near that marker can then be searched for a likely gene which causes the trait. It is hoped that genetic linkage research might eventually result in new or improved ways to determine individuals and families at higher risk for clubfoot and development of new or improved ways to treat clubfoot.

Our research staff will obtain information about each subject and their family called a pedigree. We will then administer a one page questionnaire to the mother(s) of the affected individual(s). This questionnaire will ask about the mother's experiences during pregnancy (e.g. Did she take multivitamins? Did she smoke or drink? etc.)

Each of the study participants (affected and non-affected individuals) will be asked to provide DNA from a blood sample. If collecting a blood sample is not possible we can also obtain DNA by collecting a saliva sample.

Samples for DNA processing will be stored according to the following repository guidelines. Patient/donor-subject information, questionnaires, and consents will be maintained by the orthopaedic research coordinator.

Samples will be made to investigators not affiliated with UT Southwestern who wish to study genetic factors that cause clubfoot; for example, we have recently been approached by Jacqueline Hecht (UT Health Science Center, Houston) and Matthew Dobbs (Washington University, St. Louis) regarding participation in their multicenter trials. Samples will be de-identified and will include no personal information which would link the sample to the donor subject.

Primary investigator and sub-investigators will determine how samples will be used and by whom. Additional research utilizing subjects' samples will be approved by the Texas Scottish Rite Hospital for Children Research Advisory Panel and the Institutional Review Board at UT Southwestern. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00607191
Study type	Observational
Source	Texas Scottish Rite Hospital for Children
Contact
Status	Completed
Phase	N/A
Start date	January 2008
Completion date	May 4, 2017

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT00175708` - Pedobarographic Assessments of Clubfoot Treated Patients
Recruiting	`NCT06050746` - Predictive Value of the PBS-score in Children With Clubfoot
Recruiting	`NCT06033638` - Video Documented PBS-Score in Children With Clubfoot
Recruiting	`NCT06050564` - Therapeutic Recommendations Based on Clinical History and Video Documented PBS-Score
Completed	`NCT02022267` - Gait Analysis in Ponseti Clubfoot	N/A
Completed	`NCT01481324` - Outcomes of Compliance With Brace Wear in Clubfoot	N/A
Withdrawn	`NCT00475631` - Economic Evaluation of Clubfoot Treatment: One Centre's Experience
Completed	`NCT01088828` - Exploring the Causes of Clubfoot Using Magnetic Resonance Imaging, MRI	N/A
Completed	`NCT02815306` - Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot	N/A
Not yet recruiting	`NCT01050088` - Sucrose Analgesia in Infants Undergoing Casting for Club Foot	N/A
Recruiting	`NCT00474032` - Using Botox to Treat Patients With Idiopathic Clubfoot	N/A
Recruiting	`NCT04564430` - Clonidine for Tourniquet-related Pain in Children	Phase 4
Recruiting	`NCT03249805` - MiracleFeet Foot Abduction Brace Sensor Trial	N/A
Recruiting	`NCT04766684` - Comparison Study of LMX4 Cream Versus J-Tip Needle-Free Injection System With Lidocaine for In-Office PAT for Clubfoot	Phase 4
Not yet recruiting	`NCT04737083` - CGH Array in Bilateral Clubfoot
Completed	`NCT02395185` - A Randomized Controlled Trial of Three Non-pharmacologic Analgesic Techniques for Casting of Clubfoot Infants	N/A
Completed	`NCT05456737` - Functional Assessment in Children With Clubfoot
Active, not recruiting	`NCT04693065` - Pronostic Factors of Long Term Outcome in Patients With Clubfoot Treated by the Ponseti Method
Completed	`NCT03953430` - Gait Analysis in Children With Clubfoot Treated With Tibialis Anterior Tendon Transfer

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.