ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01217463
Recruitment Status : Completed
First Posted : October 8, 2010
Results First Posted : August 5, 2014
Last Update Posted : August 5, 2014
Sponsor:
Information provided by (Responsible Party):
Olympus Biotech Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetic Foot Ulcer of Neuropathic Origin
Intervention Drug: Trafermin 0.01% spray
Enrollment 201

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trafermin Placebo
Hide Arm/Group Description Trafermin 0.01% spray: 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: 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
Period Title: Overall Study
Started 99 102
Completed 86 94
Not Completed 13 8
Reason Not Completed
Adverse Event             8             5
Physician Decision             0             1
Withdrawal by Subject             3             0
Surgery on the Target Limb             0             1
Patient Non-compliant             1             0
Other             1             1
Arm/Group Title Trafermin Placebo Total
Hide Arm/Group Description Trafermin 0.01% spray Matching placebo spray Total of all reporting groups
Overall Number of Baseline Participants 99 102 201
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) population was defined as all randomized patients who have at least one medical evaluation during the study. Demographic and baseline characteristics were presented in terms of descriptive statistics in ITT population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 99 participants 102 participants 201 participants
62.0  (10.0) 61.7  (9.4) 61.9  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 102 participants 201 participants
Female
15
  15.2%
16
  15.7%
31
  15.4%
Male
84
  84.8%
86
  84.3%
170
  84.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 102 participants 201 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
99
 100.0%
100
  98.0%
199
  99.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
2
   2.0%
2
   1.0%
Wound size ≤5cm^2  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants 102 participants 201 participants
77 80 157
Wound size >5cm^2  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants 102 participants 201 participants
22 22 44
Peripheral blood perfusion Impaired  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants 102 participants 201 participants
36 38 74
Peripheral blood perfusion Normal  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants 102 participants 201 participants
63 64 127
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 99 participants 102 participants 201 participants
30.91  (4.42) 30.65  (5.00) 30.78  (4.71)
1.Primary Outcome
Title Wound Closure Rate of Diabetic Foot Ulcers (DFUs) of Neuropathic Topical Daily Application of Trafermin 0.01% Spray Compared With Placebo, in Addition
Hide Description Wound closure is defined as 100% reepithelialization of the target DFU, without exudate.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary analysis of the efficacy criteria was conducted on the ITT population.
Arm/Group Title Trafermin Placebo
Hide Arm/Group Description:
Trafermin 0.01% spray
Matching placebo spray
Overall Number of Participants Analyzed 99 102
Measure Type: Number
Unit of Measure: percentage of participants
14.1 10.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trafermin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4109
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.44
Confidence Interval (2-Sided) 95%
0.60 to 3.43
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Relative Wound Area Regression of 40% or More at 6 Week
Hide Description The incidence of wound area regression of at least 40% at week 6 was considered as an important exploratory secondary efficacy variable. The wound area regression was calculated as percentage change from inclusion at week 6 using centralized wound area data.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis of the efficacy criteria was conducted on the ITT population.
Arm/Group Title Trafermin 0.01% Spray Matching Placebo Spray
Hide Arm/Group Description:
Trafermin 0.01% spray: 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
Trafermin 0.01% spray: 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
Overall Number of Participants Analyzed 99 102
Measure Type: Number
Unit of Measure: percentage of participants
60.9 52.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trafermin 0.01% Spray, Matching Placebo Spray
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.37
Confidence Interval (2-Sided) 95%
0.78 to 2.4
Estimation Comments [Not Specified]
Time Frame Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
Adverse Event Reporting Description The safety population included all patients who were randomized and exposed to the study treatment.
 
Arm/Group Title Trafermin Placebo
Hide Arm/Group Description Trafermin 0.01% spray Matching placebo spray
All-Cause Mortality
Trafermin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Trafermin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   23/99 (23.23%)   17/102 (16.67%) 
Blood and lymphatic system disorders     
Anemia  1  0/99 (0.00%)  1/102 (0.98%) 
Cardiac disorders     
Angina pectoris  1  0/99 (0.00%)  1/102 (0.98%) 
Cardiac failure acute  1  1/99 (1.01%)  0/102 (0.00%) 
Cardiac failure chronic  1  1/99 (1.01%)  0/102 (0.00%) 
Coronary artery stenosis  1  1/99 (1.01%)  0/102 (0.00%) 
Eye disorders     
Blindness  1  1/99 (1.01%)  0/102 (0.00%) 
Retinal hemorrhage  1  0/99 (0.00%)  1/102 (0.98%) 
Gastrointestinal disorders     
Edema peripheral  1  1/99 (1.01%)  0/102 (0.00%) 
Infections and infestations     
Abscess  1  1/99 (1.01%)  0/102 (0.00%) 
Diabetic foot infection  1  3/99 (3.03%)  3/102 (2.94%) 
Erysipelas  1  1/99 (1.01%)  2/102 (1.96%) 
Gangrene  1  1/99 (1.01%)  0/102 (0.00%) 
Osteomyelitis  1  4/99 (4.04%)  4/102 (3.92%) 
Pneumonia  1  1/99 (1.01%)  1/102 (0.98%) 
Postoperative wound infection  1  1/99 (1.01%)  0/102 (0.00%) 
Sepsis  1  1/99 (1.01%)  0/102 (0.00%) 
Injury, poisoning and procedural complications     
Femur fracture  1  0/99 (0.00%)  1/102 (0.98%) 
Wrist fracture  1  1/99 (1.01%)  0/102 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant  1  1/99 (1.01%)  0/102 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  0/99 (0.00%)  1/102 (0.98%) 
Skin and subcutaneous tissue disorders     
Toxic skin eruption  1  0/99 (0.00%)  1/102 (0.98%) 
Surgical and medical procedures     
Leg amputation  1  0/99 (0.00%)  1/102 (0.98%) 
Skin graft  1  0/99 (0.00%)  2/102 (1.96%) 
Toe amputation  1  3/99 (3.03%)  1/102 (0.98%) 
Vascular disorders     
Peripheral arterial occlusive disease  1  1/99 (1.01%)  0/102 (0.00%) 
Peripheral embolism  1  1/99 (1.01%)  0/102 (0.00%) 
Peripheral ischemia  1  1/99 (1.01%)  1/102 (0.98%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Trafermin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   20/99 (20.20%)   21/102 (20.59%) 
Infections and infestations     
Diabetic foot infection  1  9/99 (9.09%)  10/102 (9.80%) 
Metabolism and nutrition disorders     
Diabetic foot  1  11/99 (11.11%)  11/102 (10.78%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI have no implicit or explicit rights to publish study data and results of their services.
Results Point of Contact
Name/Title: Mr. Akira Kondo, Manager, Clinical R&D
Organization: Olympus France S.A.S
Phone: +33-1-4560-6849
Responsible Party: Olympus Biotech Corporation
ClinicalTrials.gov Identifier: NCT01217463     History of Changes
Other Study ID Numbers: TFM-CL3-001
2010-021014-33 ( EudraCT Number )
First Submitted: October 7, 2010
First Posted: October 8, 2010
Results First Submitted: July 2, 2014
Results First Posted: August 5, 2014
Last Update Posted: August 5, 2014