Understanding muscle connective tissue in limb development and radial dysplasia
Muscle Connective Tissue in Limb Development and Disease
King's College London · NCT02611089
This study looks at how problems in muscle tissue might cause issues in limb development for people with radial dysplasia to help improve treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Sex | All |
| Sponsor | King's College London (other) |
| Locations | 5 sites (Oxford, Oxfordshire and 4 other locations) |
| Trial ID | NCT02611089 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how disruptions in muscle connective tissue contribute to soft tissue defects in patients with radial dysplasia, a limb anomaly. Researchers will compare tissue samples from patients undergoing corrective hand surgery with those from patients having other hand surgeries to identify differences in tissue architecture and cellular composition. The goal is to enhance understanding of normal limb development and improve treatment strategies for radial dysplasia. By examining post-natal muscle connective tissue derivatives, the study seeks to address an ongoing challenge in managing this condition.
Who should consider this trial
Good fit: Ideal candidates include patients with a clinical diagnosis of radial dysplasia who require reconstructive surgery.
Not a fit: Patients with radial dysplasia who do not require reconstructive surgery or those with other diagnoses will not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved treatment options for children with radial dysplasia.
How similar studies have performed: While this approach is based on previous findings in experimental models, it is novel in its application to human patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Cases Inclusion Criteria: * Patients with a clinical diagnosis of radial dysplasia, requiring reconstructive surgery * Either sex * Informed (parental) consent to participate Exclusion Criteria: * Patients with a clinical diagnosis of radial dysplasia, but not requiring reconstructive surgery * Patients with a diagnosis other than radial dysplasia * Patients with extensive previous scarring to their forearm and hand. * Patients with a significant pathological skin or soft tissue lesion at the donor site. Controls Inclusion Criteria: * Patients with an injury requiring reconstructive surgery * Either sex * Informed (parental) consent to participate Exclusion Criteria: * Patients with extensive previous scarring to their forearm and hand. * Patients with a significant pathological skin or soft tissue lesion at the donor site.
Where this trial is running
Oxford, Oxfordshire and 4 other locations
- Oxford University Hospitals — Oxford, Oxfordshire, United Kingdom (RECRUITING)
- Royal Free Hospital — London, United Kingdom (RECRUITING)
- Guy's and St Thomas' Hospital — London, United Kingdom (RECRUITING)
- Chelsea and Westminster Hospital NHS Foundation Trust — London, United Kingdom (RECRUITING)
- Great Ormond Street Hospital for Children NHS Foundation Trust — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Branavan Sivakumar, FRCS(Plast) — Great Ormond Street Hospital for Children NHS Foundation Trust
- Study coordinator: Malcolm Logan, BSc PhD
- Email: malcolm.logan@kcl.ac.uk
- Phone: 02078486886
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: Radial Dysplasia, Muscle connective tissue, Small leucine-rich proteoglycans, Limb development