A phase 2b, multi-centre, randomized, intra-patient-controlled dose-finding study of I-020502 in patients undergoing autologous meshed skin grafting. - N/A

• Conditions: acute wounds / deep partial and full thickness burns; MedDRA version: 9.1Level: HLTClassification code 10043418Term: Thermal burns; MedDRA version: 9.1Level: LLTClassification code 10006802Term: Burns second degree; MedDRA version: 9.1Level: LLTClassification code 10006803Term: Burns third degree

• Registration Number: EUCTR2008-005115-17-DE
• Lead Sponsor: Kuros Biosurgery AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1.Written informed consent by the patient.
2.Male or female patients, aged = 18 years.
3.Female with childbearing potential with a negative pregnancy test within 10 days prior to surgery who agrees to use an acceptable birth control method (hormonal or UID) until day 28 post surgery.
4.Patients with burn wound(s) up to 50% TBSA elected for autologous mesh grafting of a meshing ratio 1:3.
5.Patients with a deep partial thickness/full thickness wound(s) of two comparable sites either contiguous or separate in the same location (e.g. leg) each sized between 1% and 2% TBSA.
6.Patients who are considered to be able to comply with the protocol.

Are the trial subjects under 18? no
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

1.Females who are pregnant or breast-feeding.
2.Patients with known or suspected allergies to any of the components of I-020502 (e.g. hypersensitivity to bovine proteins).
3.Digits, head, genitalia, palms of hands, soles of feet, and
face as test sites.
4.Electrical and/or chemical burns.
5.Clinically significant infections at wound sites.
6.Clinically significant systemic infections.
7.History or suspicion or presence of systemic or local cancer or tumor of any kind.
8.Patients previously treated with PDGF.
9.Patients with vascular or skin disorders that directly affect the designated wound site.
10.Patients with HbA1c < 7%.
11.Patients with chronic malnourishment.
12.Chronic treatment with immunosuppressive drugs, systemic corticosteroids or other chronic treatments influencing wound healing within the last 2 months prior to surgery.
13.Any other acute or chronic concurrent medical conditions that in the Investigator’s opinion compromise study participation.
14.Participation in another investigational study within 30 days prior to surgery for investigational devices, or within 3 months prior to surgery for investigational drugs.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to assess the effect of I-020502 on the incidence of wound closure in patients with deep partial thickness or full thickness burns undergoing autologous meshed skin grafting.<br><br>;Secondary Objective: To assess the safety and tolerability of I-020502.<br>To assess PDGF-AB levels and PDGF-AB / TG-PDGF.AB antibodies.<br>To assess quality of life and collect pharmacoeconomic information.<br>;Primary end point(s): Incidence of full wound closure at each test site on Day 12.<br>