Study of PXL01 Versus Placebo to Inhibit Adhesion Formation After Flexor Tendon Surgery

A Prospective Double-blind, Randomised Concept Study of PXL01 Versus Placebo in Flexor Tendon Surgery

Sponsors

Lead Sponsor: Pergamum AB

Source Pergamum AB
Brief Summary

The objectives of the study are to assess efficacy, safety, and handling of PXL01 in patients with flexor tendon injury in zone I or II.

Detailed Description

This is a multi-centre, randomized, double blind, parallel study design in patient admitted for flexor tendon repair in zone II.

The patients will undergo 9 visits within the time frame of the study. Patients will be randomized to receive treatment with PXL01 or standard care.

Primary objective is to assess total active motion based on PIP and DIP joints (TAM2) at 12-week visit. Secondary objectives are to assess TAM2 at all time points except for 12 weeks, TAM based on MCP, PIP, and DIP joints (TAM3) at all time points, Total Active Motion in DIP joint (DIPAM), tip-to-crease, grip strength and Total Passive Motion (TPM2 and TPM3).

Before any study-related assessment takes place, patients are given verbal and written information about the study and informed consent is achieved from the patient and/or legal guardian. The study should be carried out in accordance with the Clinical Study Protocol (CSP), ICH guidelines for Good Clinical Practise (GCP), and applicable regulatory requirements.

Overall Status Completed
Start Date December 2009
Completion Date February 2013
Primary Completion Date May 2012
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
TAM2 At 12 weeks after surgery
Enrollment 138
Condition
Intervention

Intervention Type: Drug

Intervention Name: PXL01

Description: PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.

Arm Group Label: PXL01

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo is a physiological sodium chloride solution, which is clear and colourless.

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion criteria:

1. Complete division of flexor digitorium profundus tendon (FDP) in zone I or II, with or without division of 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

Exclusion criteria

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 with 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

Gender: All

Minimum Age: 15 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Monica Wiig, MD, PhD Principal Investigator Dept. of Hand Surgery Uppsala University Hospital
Location
Facility:
Dept. of Hand Surgery, Aalborg Hospital | Aalborg, 9000, Denmark
Dept. of Hand Surgery, Odense University Hospital | Odense, 5000, Denmark
Klinik für Handchirurgie der Herz- und Gefäß-Klinik GmbH | Bad Neustadt, 97616, Germany
Katholisches Klinikum Duisburg, St. Barbara Hospital, Klinik für Plastische Chirurgie und Handchirurgie | Duisburg, 47166, Germany
St.Josef Hospital Essen- Kupferdreh, Abteilung für Handchirurgie | Essen, 45257, Germany
Klinik für Plastische, Hand- und Wiederherstellungschirurgie, Medizinische Hochschule Hannover | Hannover, 30625, Germany
Universitätsklinikum des Saarlandes, Klinik für Unfall-, Hand - und Wiederherstellungschirugie | Homburg, 66421, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Sektion für Plastische Chirurgie, Handchirurgie und Intensiveinheit für Schwerbrandverletzte | Lübeck, 23538, Germany
Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Innenstadt | Munich, 80336, Germany
Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Großhadern | Munich, 81377, Germany
Klinik für Handchirurgie, Mikrochirurgie und Rekonstruktive Brustchirurgie Vinzenz von Paul Kliniken GmbH | Stuttgart, 70199, Germany
Dept. of Hand Surgery Sahlgrenska University Hospital | Gothenburg, SE-413 45, Sweden
Dept. of Hand Surgery Malmö University Hospital | Malmö, SE-20502, Sweden
Dept. of Hand Surgery, Stockholm South General Hospital | Stockholm, 118 83, Sweden
Dept. of Hand Surgery Uppsala University Hospital, entrance 70 | Uppsala, SE-75185, Sweden
Location Countries

Denmark

Germany

Sweden

Verification Date

April 2014

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Placebo

Type: Placebo Comparator

Description: Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.

Label: PXL01

Type: Experimental

Description: PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.

Acronym PHSU02
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov