Trial · NCT03282981
Beta Adrenergic Antagonist for the Healing of Chronic DFU
NCT03282981, Phase 3, Completed, VA Office of Research and Development; results first posted 2025-04-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Beta Adrenergic Antagonist for the Healing of Chronic DFU. Trials, record NCT03282981. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03282981
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Beta Adrenergic Antagonist for the Healing of Chronic DFU
- NCT number
- NCT03282981
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 48 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Chronic Diabetic Foot Ulcers, Diabetic Neuropathic Ulcers, Non Healing Wound
- Interventions
- Timolol, Non biologically active gel
- First posted
- 2017-09-14
- Last updated
- 2025-05-08
- Results first posted
- 2025-04-25
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Complete Wound Closure, as Assessed Over a 12 Week Period | 12 weeks | Complete wound closure will be assessed by Investigators and is defined as 100% epithelialization of the wound site ("skin re-epithelialization without drainage or dressing requirements by Week 12). The primary outcome was the proportion of patients with complete wound healing by the end of the treatment phase, evaluated using Fisher's exact test. |
| Primary | Safety Outcome Measurement of Timolol Serum | 12 weeks | Safety outcome measurement of timolol serum during the treatment phase. Serum Timolol levels were assessed in all participants receiving SOC + Timolol. Most levels were below the detectable limit (\<0.22 ng/mL), suggesting minimal systemic absorption. Three participants exhibited detectable levels, with one case of a protocol deviation involving excessive application resulting in a serum level of 1.00 ng/mL. No systemic effects were observed in these cases, supporting the safety profile of topical Timolol. |
| Secondary | The Time to Wound Closure Between the Two Groups | 31 weeks |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Complete Wound Closure, as Assessed Over a 12 Week Period | 12 weeks | chronic, diabetic foot ulcerations | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety Outcome Measurement of Timolol Serum | 12 weeks | safety level measure of serum timolol | ng/ml | MEAN |
| SECONDARY | The Time to Wound Closure Between the Two Groups | 31 weeks | chronic diabetic foot ulcer | weeks | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Complete Wound Closure, as Assessed Over a 12 Week Period | Timolol | 8 | Participants | ||
| Percentage of Complete Wound Closure, as Assessed Over a 12 Week Period | SOC Plus Non Biologically Active Gel | 7 | Participants | ||
| Safety Outcome Measurement of Timolol Serum | Timolol | 0.596 | Standard Deviation 0.315 | ng/ml | |
| The Time to Wound Closure Between the Two Groups | Timolol | 5.8 | Standard Deviation 1.0 | weeks | |
| The Time to Wound Closure Between the Two Groups | SOC Plus Non Biologically Active Gel | 9.2 | Standard Deviation 1.0 | weeks |
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 | Timolol | 21 | |
| Overall Study | STARTED | SOC Plus Non Biologically Active Gel | 27 | |
| Overall Study | COMPLETED | Timolol | 21 | |
| Overall Study | COMPLETED | SOC Plus Non Biologically Active Gel | 24 | |
| Overall Study | NOT COMPLETED | Timolol | 0 | |
| Overall Study | NOT COMPLETED | SOC Plus Non Biologically Active Gel | 3 |
Source ClinicalTrials.gov
Adverse events4
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 |
|---|---|---|---|---|---|---|
| serious | Infection | Infections and infestations | Timolol | 0 | 21 | 0 |
| serious | Infection | Infections and infestations | SOC Plus Non Biologically Active Gel | 1 | 27 | 1 |
| serious | Lightheadedness | Metabolism and nutrition disorders | Timolol | 0 | 21 | 0 |
| serious | Lightheadedness | Metabolism and nutrition disorders | SOC Plus Non Biologically Active Gel | 1 | 27 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Timolol | 2 | 21 |
| Total, all-cause mortality | SOC Plus Non Biologically Active Gel | 5 | 27 |
| Total, other adverse events | Timolol | 0 | 21 |
| Total, other adverse events | SOC Plus Non Biologically Active Gel | 0 | 27 |
| Total, serious adverse events | Timolol | 0 | 21 |
| Total, serious adverse events | SOC Plus Non Biologically Active Gel | 2 | 27 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32513257 | DERIVED |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Timolol vs SOC Plus Non Biologically Active Gel: Percentage of Complete Wound Closure, as Assessed Over a 12 Week Period | Trial comparisons |
| Timolol vs SOC Plus Non Biologically Active Gel: deaths from any cause | Trial comparisons |
| Timolol vs SOC Plus Non Biologically Active Gel: serious adverse events | 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/NCT03282981
GET https://conductscience.org/api/trials/v1/NCT03282981/registered