Comparison Between Skin Graft Versus Skin Graft and Stem Cell Application (NCT04219657) | Clinical Trial Compass
CompletedPhase 1
Comparison Between Skin Graft Versus Skin Graft and Stem Cell Application
Pakistan110 participantsStarted 2016-10-29
Plain-language summary
Trauma is the leading cause of soft tissue loss of the heel. Children constitute the largest group of victims of such injuries. Spoke wheel injury, road traffic accident are common mode in the children. Oestern and Tscherne have classified soft tissue injuries into four grades from 0-4. The treatment of Grade 0 and 1 injuries is typical cleansing and application of a moist wound healing dressing. But further grades need surgical management with debridement and reconstruction. Grade III and IV can be reconstructed by using graft, flaps or various other techniques. . Skin grafting offers poor functional and cosmetic results, although it is commonly performed with good take rates. mesenchymal stem cells will be isolated from umbilical cord with informed consent from the mothers. This study will open a new avenue for the treatment of heel pad injury. . Since the use of stem cell (especially in Pakistan) is completely a new technique in the management of heel pad injury, it will provide insight for better management by accelerating the wound healing process.
Who can participate
Age range
8 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pediatric age group population (less than 12 years) irrespective of sex.
* Children with traumatic heel pad injury requiring skin grafting admitted through outdoor and emergency department.
Exclusion Criteria:
* Children with traumatic heel pad injury associate with other systemic injury requiring surgical/medical treatment other than skin graft/flap.
* Traumatic heel pad injury with calcaneal fracture.
* Children with traumatic heel pad injury with osteomyelitis, Idiopathic thrombocytopenic purpura, diabetes mellitus and immunodeficiency state under medication.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ranges of Movement of ankle joint
Timeframe: at 1st week of intervention and after at 12 weeks