Muscle Lesions Clinical Trial
Official title:
Platelet-derived Factors for Treatment of Muscular Lesions: a Phase II Trial
| Verified date | August 2015 |
| Source | IRCCS Policlinico S. Matteo |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Interventional |
The purpose of this study is to demonstrate that platelet-derived repairing factors are effective and safe in the treatment of muscular lesion grade 2 or 3, a Phase II, open-label, single arm, single centre has been designed. Sample size will be 25.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | May 2013 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - age > 18 years old - if woman, no pregnancy ongoing - muscular lesion grade 2 or 3 in a lower limb muscular group Exclusion Criteria: - no hematological conditions - no anticoagulation in the two preceding weeks |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Clinica Ortopedica Fondazione IRCCS Policlinico San Matteo | Pavia |
| Lead Sponsor | Collaborator |
|---|---|
| IRCCS Policlinico S. Matteo |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | number (and proportion with 95% CI) of patients able to return to sport activity (i.e. training) at 21 days from muscular injury. | If the athlete is able, 21 days after the muscular injury, to return to (at least) training activities, the outcome will be coded "successful"; and "unsuccessful" otherwise | 21 days from enrollment | No |
| Secondary | Time-to-return to sport activities | within 4 months from lesion | No | |
| Secondary | Side effects | Overall frequency of patients with any adverse events (number, proportion and 95%CI) | within 4 months from treatment | Yes |
| Secondary | time-to-healing at ultrasound | within 4 months from treatment | No | |
| Secondary | side effects | types of side effects (number, proportion and 95%CI for each type of adverse events) | within 4 months from treatment | Yes |
| Secondary | side effects | grade of side effects (number, proportion and 95%CI for each grade of adverse events) | within 4 months from treatment | Yes |