Patients with flexor tendon injuries in zone I or II that are admitted to the respective site will be considered for inclusion and informed about the study. MedDRA version: 14.1 Level: PT Classification code 10043248 Term: Tendon rupture System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Product Name: PXL01
Product Code: PXL01
Pharmaceutical Form: Concentrate for solution for injection
Current Sponsor code: PXL01
Other descriptive name: PXL01 is a peptide sequence derived from human l
Sponsors
Pergamum AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following entry criteria apply: 1. Complete division of flexor digitorium profundus tendon (FDP) in zone I or II, with or without division of the flexor digitorium superficialis (FDS) and possible to rejoin with tendon suture 2. Open flexor tendon injury sutured within 14 days after trauma 3. 12-75 years of age 4. Signed informed consent prior to any study related procedures Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: If one or more of the following criteria are fulfilled, the patient should not be included in the study: 1. Treatment with any investigational product within 4 weeks of study entry 2. Patients previously included in the study 3. Thumbs with complete or partial division of flexor pollicis longus (FPL) 4. Concomitant fracture(s) requiring immobilisation 5. Injuries with associated soft tissue loss 6. Severe crush injury 7. Palmar plate injury requiring immobilisation 8. Devascularisation/requirement of vascular repair 9. Joint injuries 10. Bilateral injuries 11. Previous flexor tendon surgery in the digit, which is to be treated wih IMP 12. Reduced motion in the digit, which is to be treated with IMP, or the corresponding digit prior to the injury 13. Compliance with mobilisation protocol not expected 14. Alcohol or drug abuse 15. Severe intercurrent illness, which in the opinion of the Investigator, may put the patient at risk when participating in the study, or affect the patient’s ability to take part in the study 16. Pregnant or lactating females 17. Fertile women who do not accept the consistent and correct use of highly effective methods of birth control defined as implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s, sexual abstinence or vasectomised partner during the first two weeks post-surgery. A condom alone is not considered an acceptable method for birth control, not even together with spermicide. 18. Known allergy to any component of the study product or placebo 19. Patients suffering from: - Diabetes Mellitus patients where significant diabetic complications may delay healing according to the investigator’s judgement - Rheumatoid arthritis 20. Or patients treated with: - Systemic steroids within one month - Immunosuppressive drugs within three months - Daily use of NSAIDs within one week or occasional use within 8 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of a single local administration of 20 mg/ml PXL01 in sodium hyaluronate in patients with a flexor tendon injury in zone I or II. ;Secondary Objective: The secondary objectives are to evaluate additional efficacy variables and safety, including rupture rate, of a single local administration of 20 mg/ml PXL01 in sodium hyaluronate in patients with a flexor tendon injury in zone I or II. Exploratory analysis of prognostic factors and covariates of Poor Responders will be performed. In addition, the IMP users’ thoughts about product handling and administration will be evaluated.;Primary end point(s): The primary variable is Total Active Motion (TAM) at the proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints (i.e. TAM2) of the affected digit at actively made fist at 12 weeks after surgery. | — |
Countries
Denmark, Germany, Sweden
Contacts
Public ContactMargit Mahlapuu
Pergamum AB
Outcome results
None listed