The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Southern Europe The TRANS-South Study

NCT01217463 | Completed Phase 3 Results DMC

• 2 other identifiers: TFM-CL3-0012010-021014-33
• Study Type: interventional
• Target: 201
• Locations: 4 countries
• Sites: 24

Brief Summary

Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan). Trafermin 0.01% cutaneous spray product kit consisting of a glass bottle containing lyophilized trafermin, a glass bottle with solvent for solution and a spray part to fit the glass bottle after reconstitution of the final product. The investigators conduct a multinational, randomized, double-blind, placebo controlled, parallel-group, multicentre study consisting of a placebo run-in phase (2w), a treatment phase (max. 12w) and a follow-up phase (3mo+6mo). The primary objective of the study is to demonstrate a superior wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin after 12 weeks topical daily application of trafermin 0.01% spray compared with placebo, in addition to best local care (off-loading, dressings). Approximately 210 patients will be randomized and it is planned that this study will be conducted at approximately 30 investigational sites in an estimated 4 countries in Europe (Czech Republic,France,Hungary,Italy,).

Conditions

Diabetic Foot Ulcer of Neuropathic Origin

Keywords

Diabetic foot; Neuropathic; Wound; Growth factor

Outcome Measures

Primary Outcomes (1)

• Wound Closure Rate of Diabetic Foot Ulcers (DFUs) of Neuropathic Topical Daily Application of Trafermin 0.01% Spray Compared With Placebo, in Addition

  Wound closure is defined as 100% reepithelialization of the target DFU, without exudate.

  12 weeks

Secondary Outcomes (1)

• Relative Wound Area Regression of 40% or More at 6 Week

  6 weeks

Study Arms (2)

Trafermin 0.01% spray

ACTIVE COMPARATOR

Drug: Trafermin 0.01% spray

Matching placebo spray

PLACEBO COMPARATOR

Drug: Trafermin 0.01% spray

Interventions

Trafermin 0.01% spray DRUG

For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is \>6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface

Matching placebo spray; Trafermin 0.01% spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Provide written informed consent to participate.
• Male or female patients age 18 years or older.
• Type 1 or 2 diabetes.
• A single full-thickness DFU that has been present for at least 2 weeks.
• DFU wound surface area below or equal 34 cm2 on the target foot.
• No exposure of bone in the target DFU.
• Neuropathy confirmed by loss of protective sensation to monofilament test (Semmes-Weinstein 5.07 monofilament).
• No predominant ischemia requiring further exploration or treatment, and confirmed by either:
• ABPI on the target leg ( \>0.9;below or equal 1.3) or if ABPI is \>1.3 or is not assessable,TBPI on target foot above or equal 0.7, OR
• ABPI on target leg (above or equal 0.7;below or equal 0.9) or if ABPI is \>1.3 or is not assessable, TBPI on target foot \<0.7, AND a toe blood pressure \>40 mmHg
• Patients who fulfill all of the following criteria are eligible for randomization:
• Completed the 2-week placebo run-in period during which they were compliant to off-loading and to daily application of placebo spray, without major protocol violation. Compliance with the placebo run-in treatment regimen must be "excellent" or "acceptable"
• Glycosylated hemoglobin (HbA1c) below or equal 10% (from a blood sample taken during the placebo run-in period).
• Non-infected target foot DFU of confirmed neuropathic origin with:
• ABPI on the target leg (\>0.9;below or equal 1.3) or if ABPI is \>1.3 or is not assessable,TBPI on target foot above or equal 0.7, OR

Sponsors & Collaborators

• Olympus Biotech Corporation: lead

Study Sites (24)

Unknown Facility

Ostrava- Vitkovice, 70300, Czechia

Location

Unknown Facility

Prague, 10034, Czechia

Location

Unknown Facility

Prague, 14021, Czechia

Location

Unknown Facility

Prague, 15006, Czechia

Location

Unknown Facility

Prague, 18200, Czechia

Location

Unknown Facility

Bron, France

Location

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Lisieux, France

Location

Unknown Facility

Montpellier, France

Location

Unknown Facility

Budapest, 1036, Hungary

Location

Unknown Facility

Budapest, 1095, Hungary

Location

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Budapest, 1097, Hungary

Location

Unknown Facility

Kisvárda, Hungary

Location

Unknown Facility

Sátoraljaújhely, Hungary

Location

Unknown Facility

Szeged, Hungary

Location

Unknown Facility

Szekszárd, Hungary

Location

Unknown Facility

Abbiategrasso, Italy

Location

Unknown Facility

Campobasso, Italy

Location

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Milan, Italy

Location

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Montfalcone, Italy

Location

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Padua, Italy

Location

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Paola, Italy

Location

Unknown Facility

Pisa, Italy

Location

Unknown Facility

Pistoia, Italy

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Unknown Facility

Rome, Italy

Location

MeSH Terms

Conditions

Diabetic Foot; Wounds and Injuries

Interventions

trafermin

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Mr. Akira Kondo, Manager, Clinical R&D
• Organization: Olympus France S.A.S

akira.kondo@olympus.fr

+33-1-4560-6849

Study Officials

• Jean-Charles Kerihuel, MD

  VERTICAL

  STUDY DIRECTOR

• Luc Téot, MD

  Montpellier University Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 8, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: February 1, 2013
• Last Updated: August 5, 2014
• Results First Posted: August 5, 2014

Record last verified: 2014-08

Locations

CZ (5); HU (7); IT (9); FR (3)