Trial · NCT01217463
The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Southern Europe The TRANS-South Study
NCT01217463, Phase 3, Completed, Olympus Biotech Corporation; results first posted 2014-08-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Southern Europe The TRANS-South Study. Trials, record NCT01217463. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01217463
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Southern Europe The TRANS-South Study
- NCT number
- NCT01217463
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 201 participants, actual
- Lead sponsor
- Olympus Biotech Corporation
- Conditions
- Diabetic Foot Ulcer of Neuropathic Origin
- Interventions
- Trafermin 0.01% spray
- First posted
- 2010-10-08
- Last updated
- 2014-08-05
- Other registries' IDs
- eudract:2010-021014-33
- Results first posted
- 2014-08-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Wound Closure Rate of Diabetic Foot Ulcers (DFUs) of Neuropathic Topical Daily Application of Trafermin 0.01% Spray Compared With Placebo, in Addition | 12 weeks | Wound closure is defined as 100% reepithelialization of the target DFU, without exudate. |
| Secondary | Relative Wound Area Regression of 40% or More at 6 Week | 6 weeks | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Wound Closure Rate of Diabetic Foot Ulcers (DFUs) of Neuropathic Topical Daily Application of Trafermin 0.01% Spray Compared With Placebo, in Addition | 12 weeks | The primary analysis of the efficacy criteria was conducted on the ITT population. | percentage of participants | NUMBER |
| SECONDARY | Relative Wound Area Regression of 40% or More at 6 Week | 6 weeks | The analysis of the efficacy criteria was conducted on the ITT population. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Wound Closure Rate of Diabetic Foot Ulcers (DFUs) of Neuropathic Topical Daily Application of Trafermin 0.01% Spray Compared With Placebo, in Addition | Trafermin | 14.1 | percentage of participants | ||
| Wound Closure Rate of Diabetic Foot Ulcers (DFUs) of Neuropathic Topical Daily Application of Trafermin 0.01% Spray Compared With Placebo, in Addition | Placebo | 10.8 | percentage of participants | ||
| Relative Wound Area Regression of 40% or More at 6 Week | Trafermin 0.01% Spray | 60.9 | percentage of participants | ||
| Relative Wound Area Regression of 40% or More at 6 Week | Matching Placebo Spray | 52.9 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Trafermin | 99 | |
| Overall Study | STARTED | Placebo | 102 | |
| Overall Study | COMPLETED | Trafermin | 86 | |
| Overall Study | COMPLETED | Placebo | 94 | |
| Overall Study | NOT COMPLETED | Trafermin | 13 | |
| Overall Study | NOT COMPLETED | Placebo | 8 |
Source ClinicalTrials.gov
Adverse events58
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diabetic foot infection | Infections and infestations | Trafermin | 9 | 99 | |
| other | Diabetic foot infection | Infections and infestations | Placebo | 10 | 102 | |
| other | Diabetic foot | Metabolism and nutrition disorders | Trafermin | 11 | 99 | |
| other | Diabetic foot | Metabolism and nutrition disorders | Placebo | 11 | 102 | |
| serious | Anemia | Blood and lymphatic system disorders | Trafermin | 0 | 99 | |
| serious | Anemia | Blood and lymphatic system disorders | Placebo | 1 | 102 | |
| serious | Angina pectoris | Cardiac disorders | Trafermin | 0 | 99 | |
| serious | Angina pectoris | Cardiac disorders | Placebo | 1 | 102 | |
| serious | Cardiac failure acute | Cardiac disorders | Trafermin | 1 | 99 | |
| serious | Cardiac failure acute | Cardiac disorders | Placebo | 0 | 102 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trafermin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Trafermin | 20 | 99 |
| Total, other adverse events | Placebo | 21 | 102 |
| Total, serious adverse events | Trafermin | 23 | 99 |
| Total, serious adverse events | Placebo | 17 | 102 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Trafermin vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01217463
GET https://conductscience.org/api/trials/v1/NCT01217463/events?page=2