Muscle Lesions
Conditions
Keywords
muscular lesions grade 2, muscular lesions grade 3
Brief summary
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.
Interventions
BIOLOGICALplatelet-derived repairing factors
autologous platelet lysate injection within 24 hours from lesion
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number (and proportion with 95% CI) of patients able to return to sport activity (i.e. training) at 21 days from muscular injury. | 21 days from enrollment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-return to sport activities | within 4 months from lesion | — |
| Side effects | within 4 months from treatment | Overall frequency of patients with any adverse events (number, proportion and 95%CI) |
| time-to-healing at ultrasound | within 4 months from treatment | — |
| side effects | within 4 months from treatment | types of side effects (number, proportion and 95%CI for each type of adverse events) |
Countries
Italy
Outcome results
None listed