Platelet-derived Factors for Treatment of Muscular Lesions
Phase 2
Completed
- Conditions
- Muscle Lesions
- Interventions
- Biological: platelet-derived repairing factors
- Registration Number
- NCT01381770
- Lead Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Platelet-derived repairing factors platelet-derived repairing factors -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method side effects within 4 months from treatment grade of side effects (number, proportion and 95%CI for each grade of adverse events)
time-to-healing at ultrasound within 4 months from treatment 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)
Trial Locations
- Locations (1)
Clinica Ortopedica Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy