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OpenTrials
Completed

NCT Number: NCT01381770

Platelet-derived Factors for Treatment of Muscular Lesions

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.

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Key information

Conditions

Muscle Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinica Ortopedica Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

platelet-derived repairing factors

Biological

autologous platelet lysate injection within 24 hours from lesion

Primary outcomes

  1. number (and proportion with 95% CI) of patients able to return to sport activity (i.e. training) at 21 days from muscular injury.

    Time frame: 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 outcomes

  1. Time-to-return to sport activities

    Time frame: within 4 months from lesion

  2. Side effects

    Time frame: within 4 months from treatment

    Overall frequency of patients with any adverse events (number, proportion and 95%CI)

  3. time-to-healing at ultrasound

    Time frame: within 4 months from treatment

  4. side effects

    Time frame: within 4 months from treatment

    types of side effects (number, proportion and 95%CI for each type of adverse events)

  5. side effects

    Time frame: within 4 months from treatment

    grade of side effects (number, proportion and 95%CI for each grade of adverse events)

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

Platelet-derived Factors for Treatment of Muscular Lesions: a Phase II Trial

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jun 27, 2011
Registry last updated
Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.