Status:
COMPLETED
An Investigation of Tendoncel, a Novel Topical Platelet Lysate Gel, in the Treatment of Lateral Epicondylitis
Lead Sponsor:
Cell Therapy Ltd.
Collaborating Sponsors:
George Papanicolaou Hospital
Conditions:
Lateral Epicondylitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Current treatments for lateral epicondylitis include: rest, behaviour modification and physiotherapy, anti-inflammatory medication - both steroidal and non-steroidal, and surgery. Current experimental...
Detailed Description
Lateral epicondylitis, also called "tennis elbow" is a common condition affecting 1 to 3% of the population; most commonly individuals aged 35 to 55 years. It is frequently self limiting but can lead ...
Eligibility Criteria
Inclusion
- Subjects aged 18 years and over and in good general health
- Subjects who have a diagnosis of lateral epicondylitis, Cozen's test
- Subjects who are willing to attend all study assessments and follow-up appointments
- Subjects who are able to understand the study, and are willing to co-operate with the study procedures and restrictions
Exclusion
- Subjects have been receiving additional concurrent treatment (e.g. surgical or steroid injection) for lateral epicondylitis.
- Subjects who have medial epicondylitis or another condition of the elbow (test side only)
- Subjects who have participated in any clinical study during the previous 30 days of initiation of this study
- Subjects with a history of alcohol, substance or drug abuse in the previous 12 months
- Subjects with any significant concurrent illness
- Subjects with a heart pacemaker
- Subjects with diabetes either type I or type II (owing to possible poor wound healing)
- Subjects that have undergone surgery in the past 3 months
- Subjects with any active or significant history of skin disorders at the treatment area(s) e.g. hypo pigmentation (vitiligo)
- Subjects with any inflammatory skin condition (eczema, psoriasis, herpes simplex/complex)
- Subjects with a history (or family history) of skin cancer, skin tumours or any other malignant disease
- Subjects with any irritation, tattoo's, piercings, scars, birthmarks, or heavy presence of freckles at the treatment site(s)
- Subjects currently taking anti-histamine or steroid medication
- Subject who due to impaired mobility would not be able to undertake independent care
- Subjects who are pregnant or who are breast feeding.
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03811145
Start Date
May 1 2014
End Date
November 1 2015
Last Update
December 12 2019
Active Locations (1)
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1
Orthopaedic Clinic of Aristotle University of Thessaloniki, General Hospital of Papanikolaou
Thessaloniki, Greece, 57010