NCT01022242

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2009

Typical duration for phase_2

Geographic Reach
3 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 29, 2014

Completed
Last Updated

May 29, 2014

Status Verified

April 1, 2014

Enrollment Period

2.4 years

First QC Date

November 25, 2009

Results QC Date

February 4, 2014

Last Update Submit

April 30, 2014

Conditions

Surgical Adhesions

Keywords

Surgical AdhesionsPost-surgical adhesionsFlexor tendon

Outcome Measures

Primary Outcomes (1)

  • TAM2

    The primary variable is TAM2: The sum of Total Active Motion at the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints of the affected digit at actively made fist minus the extensor lag at these joints.

    At 12 weeks after surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

PXL01

EXPERIMENTAL

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.

Drug: PXL01

Interventions

PXL01DRUG

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.

PXL01
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Open flexor tendon injury sutured within 14 days after trauma
  • years of age
  • Signed informed consent prior to any study related procedures

You may not qualify if:

  • Treatment with any investigational product within 4 weeks of study entry
  • Patients previously included in the study
  • Thumbs with complete or partial division of flexor pollicis longus (FPL)
  • Concomitant fracture(s) requiring immobilisation
  • Injuries with associated soft tissue loss
  • Severe crush injury
  • Palmar plate injury requiring immobilisation
  • Devascularisation/requirement of vascular repair
  • Joint injuries
  • Bilateral injuries
  • Previous flexor tendon surgery in the digit, which is to be treated with IMP
  • Reduced motion in the digit, which is to be treated with IMP, or the corresponding digit prior to the injury
  • Compliance with mobilisation protocol not expected
  • Alcohol or drug abuse
  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Dept. of Hand Surgery, Aalborg Hospital

Aalborg, 9000, Denmark

Location

Dept. of Hand Surgery, Odense University Hospital

Odense, 5000, Denmark

Location

Klinik für Handchirurgie der Herz- und Gefäß-Klinik GmbH

Bad Neustadt an der Saale, 97616, Germany

Location

Katholisches Klinikum Duisburg, St. Barbara Hospital, Klinik für Plastische Chirurgie und Handchirurgie

Duisburg, 47166, Germany

Location

St.Josef Hospital Essen- Kupferdreh, Abteilung für Handchirurgie

Essen, 45257, Germany

Location

Klinik für Plastische, Hand- und Wiederherstellungschirurgie, Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum des Saarlandes, Klinik für Unfall-, Hand - und Wiederherstellungschirugie

Homburg, 66421, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Sektion für Plastische Chirurgie, Handchirurgie und Intensiveinheit für Schwerbrandverletzte

Lübeck, 23538, Germany

Location

Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Innenstadt

Munich, 80336, Germany

Location

Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Großhadern

Munich, 81377, Germany

Location

Klinik für Handchirurgie, Mikrochirurgie und Rekonstruktive Brustchirurgie Vinzenz von Paul Kliniken GmbH

Stuttgart, 70199, Germany

Location

Dept. of Hand Surgery Sahlgrenska University Hospital

Gothenburg, SE-413 45, Sweden

Location

Dept. of Hand Surgery Malmö University Hospital

Malmo, SE-20502, Sweden

Location

Dept. of Hand Surgery, Stockholm South General Hospital

Stockholm, 118 83, Sweden

Location

Dept. of Hand Surgery Uppsala University Hospital, entrance 70

Uppsala, SE-75185, Sweden

Location

Related Publications (1)

  • Wiig ME, Dahlin LB, Friden J, Hagberg L, Larsen SE, Wiklund K, Mahlapuu M. PXL01 in sodium hyaluronate for improvement of hand recovery after flexor tendon repair surgery: randomized controlled trial. PLoS One. 2014 Oct 23;9(10):e110735. doi: 10.1371/journal.pone.0110735. eCollection 2014.

    PMID: 25340801DERIVED

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

High drop out rate leading to a low number of subjects analyzed.

Results Point of Contact

Title
Monica Wiig
Organization
Uppsala University Hospital
monica.wiig@akademiska.se

Study Officials

  • Monica Wiig, MD, PhD

    Dept. of Hand Surgery Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2009

First Posted

December 1, 2009

Study Start

December 1, 2009

Primary Completion

May 1, 2012

Study Completion

February 1, 2013

Last Updated

May 29, 2014

Results First Posted

May 29, 2014

Record last verified: 2014-04

Locations

SE(4)DE(9)DK(2)