UlcerPhase 2NCT00368602
Beta Blocker for Chronic Wound Healing
A Phase 2 study testing Timoptic in people with Ulcer and Burns, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of treatment of chronic cutaneous ulcers and burn wounds with topical beta adrenergic antagonists (Timoptic®). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- What is being tested?
- Timoptic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jun 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any race btwn 18 and 85 years of age, inclusive;
- Male or female, neither pregnant nor lactating.
- Informed consent;
- Have at least 1 lower extremity ulcer in the gaiter area (knee to ankle):
- Surface area of ≥2 sq. cm. to ≤20 sq. cm.; Ulcer with largest surface area meeting inclusion criteria will be selected.
- If 2 ulcers present with the same surface area, ulcer of longest duration selected.
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- Study ulcer must be at least 2 cm from any other ulcer on same extremity.
- A viable wound bed free of necrotic tissue post-debridement, if debridement is indicated.
- 5. Have an Ankle Brachial Index (ABI) >0.7; 6. Presence of either dorsalis pedis or posterior tibialis pulses by Doppler on the study extremity; 7. Have a non-healing (open) ulcer for at least 1 month. Subjects who failed conservative therapy are eligible for the study; 8. Comply with a trial (13 to 17 days) of protocol-specified standard care prior to randomization; 9. Two or more of the following: dermatitis, atrophie blanche, varicosities, hyperpigmentation or lipodermatosclerosis;
Who cannot join
- Decrease in wound surface area of >35% btwn Screening and Visit 1 (Randomization);
- Cellulitis, osteomyelitis, ulcer with exposed bone, tendon or fascia, or purulent exudates in ulcer area;
- Grade IV ulcer;
- Evidence of study ulcer infection;
- Study ulcer of non-venous etiology;
- Acquired or are known to be infected with HIV;
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- Uncontrolled diabetes mellitus;
- Immunodeficiency as defined by serum IgG, IgA, and IgM less than one-half the lower limit of normal;
- Severe protein malnutrition as defined by serum albumin <2.5 g/dL;
- Severe anemia defined as a total of hemoglobin of <10 g/dL for males or <8 g/dL for females;
- Chronic renal insufficiency requiring dialysis;
- Serum aspartate aminotransferase (AST, SGOT, GOT) or serum alanine aminotransferase (ALT, SGPT, GPT) levels greater than twice the upper limit of normal;
- New York Heart Association Functional Classification of IV;
- Deep vein thrombosis (DVT) w/in last 6 weeks or clinical evidence of current DVT;
- Arterial revascularization of the study extremity w/in previous 6 months from the date of Screening Visit;
- History, w/in previous 12 months from date of Screen Visit, of alcohol or drug abuse, particularly methadone or heroin;
- Received previous treatment with the following during the 60 days prior to Screening: Immunosuppressive agents, radiation, chemotherapy, growth factors at the site of the study ulcer, split- or full-thickness skin graft at the site of the study ulcer, biologically-active cellular or acellular product(s) at the site of the study ulcer, investigational drug or device
- Received previous treatment with systemic corticosteroids prior to Screening (Chronic corticosteroids w/in 90 days or short course corticosteroids w/in 30 days)
- Been hospitalized for treatment of any venous ulcer w/in the previous 30 days from Screening.
- Asthma or a history of asthma, obstructive pulmonary disease, myasthenia gravis, hyperthyroidism, history of heart block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beta Adrenergic Receptor Modulation of Burn Wound Healing
The purpose of this study is to evaluate the efficacy and safety of treatment of chronic cutaneous ulcers and burn wounds with topical beta adrenergic antagonists (Timoptic®).
Read the detailed description
The purpose of this study is to learn more about how to heal venous leg ulcers faster and to test the safety of a drug and see what effects it has on a venous leg ulcer.
You will:
- be interviewed and examined
- have a physical exam
- have blood and urine tested
- have photographs taken of the wound
- apply medication to the leg ulcer as directed
- Being tested
- Timoptic, Placebo
- Medical subject headings
- Ulcer, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TimopticDrug
Also called beta adrenergic antagonists
Timoptic to be applied to the target wound daily for up to 12 weeks.
PlaceboOther
Saline solution with no active ingredients to be applied to the target wound daily for up to 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | This group receives topical beta adrenergic antagonists (Timoptic) plus standard of care. Receives: Drug: Timoptic |
| 2 | Placebo comparator | The group will be given standard of care with placebo medication. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy parameter will be complete ulcer healing, which is defined as 100% epithelialization with no drainage or need for an absorptive dressing.
Measured: 12 weeks
Secondary outcomes (1)
100% re-epithelialization will be clinically determined at each visit by the Investigator.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2006 (estimated)
- Study startJun 2005
- Primary completionJun 2007
- Study completionJun 2007
Why it stopped: Lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rivkah R Isseroff, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368602
- Sponsor's protocol ID
- 05-06-00351
- Status last verified
- Apr 2015
- First submitted
- 24 Aug 2006
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta Adrenergic Receptor Modulation of Burn Wound Healing
- ClinicalTrials.gov ID
- NCT00368602
- Acronym / sponsor ID
- 05-06-00351
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 25 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of treatment of chronic cutaneous ulcers and burn wounds with topical beta adrenergic antagonists (Timoptic®).
Detailed description
The purpose of this study is to learn more about how to heal venous leg ulcers faster and to test the safety of a drug and see what effects it has on a venous leg ulcer.
You will:
- be interviewed and examined
- have a physical exam
- have blood and urine tested
- have photographs taken of the wound
- apply medication to the leg ulcer as directed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TimopticThis group receives topical beta adrenergic antagonists (Timoptic) plus standard of care. |
| 2 | Placebo comparator | Other: PlaceboThe group will be given standard of care with placebo medication. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Any race btwn 18 and 85 years of age, inclusive;
- Male or female, neither pregnant nor lactating.
- Informed consent;
- Have at least 1 lower extremity ulcer in the gaiter area (knee to ankle):
- 5. Have an Ankle Brachial Index (ABI) >0.7; 6. Presence of either dorsalis pedis or posterior tibialis pulses by Doppler on the study extremity; 7. Have a non-healing (open) ulcer for at least 1 month. Subjects who failed conservative therapy are eligible for the study; 8. Comply with a trial (13 to 17 days) of protocol-specified standard care prior to randomization; 9. Two or more of the following: dermatitis, atrophie blanche, varicosities, hyperpigmentation or lipodermatosclerosis;
Key exclusion criteria (20 listed)
- Decrease in wound surface area of >35% btwn Screening and Visit 1 (Randomization);
- Cellulitis, osteomyelitis, ulcer with exposed bone, tendon or fascia, or purulent exudates in ulcer area;
- Grade IV ulcer;
- Evidence of study ulcer infection;
- Study ulcer of non-venous etiology;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TimopticAlso: beta adrenergic antagonistsTimoptic to be applied to the target wound daily for up to 12 weeks. | Drug | 1 |
| PlaceboSaline solution with no active ingredients to be applied to the target wound daily for up to 12 weeks. | Other | 2 |
Primary outcome
The primary efficacy parameter will be complete ulcer healing, which is defined as 100% epithelialization with no drainage or need for an absorptive dressing.
Time frame: 12 weeks
1 secondary outcome
100% re-epithelialization will be clinically determined at each visit by the Investigator.
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Lack of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- University of California-Davis Department of Dermatology Clinical ResearchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rivkah R Isseroff, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Timoptic in people with Ulcer and Burns, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy parameter will be complete ulcer healing, which is defined as 100% epithelialization with no drainage or need for an absorptive dressing. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.