Diabetic UlcersNCT02361437
Safety and Efficacy of Vasculera® in the Healing of Diabetic Skin Ulcers
A study testing Vasculera in people with Diabetic Ulcers, run by Primus Pharmaceuticals at 1 site in United States.
Trial summary
This study is designed to evaluate if Vasculera, a marketed medical food product, will improve the rate and extent of healing of diabetic ulcers. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Diabetic Ulcers
- What is being tested?
- Vasculera
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Oct 2015
- Phase
- Interventional
- 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 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Either gender, between 25-85 years old
- Diagnosis of type II diabetes
- Presence of a grade I-III skin ulcer of diabetic origin and at least 1 cm in diameter for more than 60 days and not improving despite standard conventional care without HBOT
- Treatment with oral anti-diabetic agents and/or insulin for at least 1 year. Dose must be stable for at least 3 months.
- Not using any other product for control of serum glucose including medical foods, neutraceuticals or dietary supplements
- Consistent dietary habits
- Able to understand and sign informed consent document
Who cannot join
- age less than 25 years or greater than 85 years
- Skin ulceration of other than diabetic etiology
- diagnosis of type I diabetes
- use of any other serum glucose modifying agent, other than stable prescribed anti-diabetic medication regimen within 12 weeks of screening visit
- use of nutritional supplements specifically for anti-oxidative purposes (e.g., multivitamins allowed)
- history of collagen vascular disease
Show all 23Show fewer
- taking corticosteroids in any dose, by any route
- no history of therapy with pentoxyphylline or cilostazol for 2 months prior to the screening visit and for the duration of the study
- history of any intestinal disease that might interfere with absorption of study products
- any active malignancy or history of malignancy within 3 years of the screening visit,, except basal cell carcinoma or cervical carcinoma in situ curatively treated
- screening AST, ALT, alkaline phosphatase, bilirubin >1.3 times the upper limit of normal for the reference laboratory
- serum creatinine >3.0
- diabetes mellitus not on stable therapy for at least 3 months
- history of chronic pancreatitis
- uncontrolled hypertension (DBP >100, SPB >160)
- unstable angina, other uncontrolled cardiac disease including NYHA CHF Class III or IV
- pregnant or lactating women
- known history of allergies to citrus, diosmin, or Alka-4 Complex
- history of substance abuse, or any psychiatric condition that may impair the subject's ability to comply with the study requirements.
- Consumption of more than one (1) unit of alcohol daily. For the purposes of this study a unit of alcohol is defined as 12 oz. of beer, 6 oz. of wine or 1.5 oz. of hard spirits
- Concomitant use of chlorzoxazone, diclofenac or metronidazole
- any medical condition that, in the opinion of the investigator, might put the subject at undue risk or might interfere with the subject's ability to participate in the study
- participation in another clinical trial within 30 days or 7 half-lives of the prior study product, whichever is longer, of the screening visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Vasculera® in the Healing of Diabetic Skin Ulcers and Improving Insulin Sensitivity: A Pilot Study
This study is designed to evaluate if Vasculera, a marketed medical food product, will improve the rate and extent of healing of diabetic ulcers.
Read the detailed description
This study is designed primarily to compare the rate and extent of healing of diabetic ulcers in people treated with or without Vasculera while maintaining a standard of care (SOC) therapeutic regimen. The study will also examine the effects of Vasculera on anti-diabetic medication requirements and markers of microvascular disease. Subjects will be stratified by whether or not they receive hyperbaric oxygen therapy (HBOT) as part of their SOC treatment regimen. In addition, the study will examine the ability of Vasculera to improve glycemic control and reduce anti-diabetic medication requirements (oral or injectable insulin) and will gather preliminary information on the ability of Vasculera to improve microvascular blood flow and oxygen delivery peripheral tissues including ulcerative lesions.
- Conditions
- Diabetic Ulcers
- Being tested
- Vasculera
- Keywords
- diabetes type II, diabetic ulcers
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasculeraDietary supplement
Also called diosmin
Vasculera 630 mg b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo Receives: Dietary Supplement: Vasculera |
| Vasculera | Experimental | diosmin Receives: Dietary Supplement: Vasculera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of healing of diabetic ulcers measured by ulcer size
days to complete healinh
Measured: 4 months
Secondary outcomes (3)
Efficacy of diabetic control measure by reduction of oral anti-diabetic medication and/or insulin requirements
anti-diabetic medication doses
Measured: 4 months
Reduction on peripheral edema measured by leg circumferance
leg circumference
Measured: 4 months
lower extremity skin oxygenation measured by trancutaneous oximetry
transcutaneous oximetry at toes
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2015
- Study completionOct 2015
Why it stopped: Investigator's hospital sold and study cancelled without enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic UlcersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Primus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert M Levy, MD, Study director, Primus Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361437
- Sponsor's protocol ID
- PVD-01
- Status last verified
- Oct 2015
- First submitted
- 4 Feb 2015
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Vasculera® in the Healing of Diabetic Skin Ulcers and Improving Insulin Sensitivity: A Pilot Study
- ClinicalTrials.gov ID
- NCT02361437
- Acronym / sponsor ID
- PVD-01
- Conditions
- Diabetic Ulcers
- Keywords
- diabetes type II, diabetic ulcers
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator's hospital sold and study cancelled without enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Primus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2015 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 Feb 2015 (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.
This study is designed to evaluate if Vasculera, a marketed medical food product, will improve the rate and extent of healing of diabetic ulcers.
Detailed description
This study is designed primarily to compare the rate and extent of healing of diabetic ulcers in people treated with or without Vasculera while maintaining a standard of care (SOC) therapeutic regimen. The study will also examine the effects of Vasculera on anti-diabetic medication requirements and markers of microvascular disease. Subjects will be stratified by whether or not they receive hyperbaric oxygen therapy (HBOT) as part of their SOC treatment regimen. In addition, the study will examine the ability of Vasculera to improve glycemic control and reduce anti-diabetic medication requirements (oral or injectable insulin) and will gather preliminary information on the ability of Vasculera to improve microvascular blood flow and oxygen delivery peripheral tissues including ulcerative lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: Vasculeraplacebo |
| Vasculera | Experimental | Dietary Supplement: Vasculeradiosmin |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Either gender, between 25-85 years old
- Diagnosis of type II diabetes
- Presence of a grade I-III skin ulcer of diabetic origin and at least 1 cm in diameter for more than 60 days and not improving despite standard conventional care without HBOT
- Treatment with oral anti-diabetic agents and/or insulin for at least 1 year. Dose must be stable for at least 3 months.
- Not using any other product for control of serum glucose including medical foods, neutraceuticals or dietary supplements
Key exclusion criteria (23 listed)
- age less than 25 years or greater than 85 years
- Skin ulceration of other than diabetic etiology
- diagnosis of type I diabetes
- use of any other serum glucose modifying agent, other than stable prescribed anti-diabetic medication regimen within 12 weeks of screening visit
- use of nutritional supplements specifically for anti-oxidative purposes (e.g., multivitamins allowed)
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 |
|---|---|---|
| VasculeraAlso: diosminVasculera 630 mg b.i.d. | Dietary supplement | Vasculera, placebo |
Primary outcome
Rate of healing of diabetic ulcers measured by ulcer size
Time frame: 4 months
days to complete healinh
3 secondary outcomes
Efficacy of diabetic control measure by reduction of oral anti-diabetic medication and/or insulin requirements
Time frame: 4 months
Reduction on peripheral edema measured by leg circumferance
Time frame: 4 months
lower extremity skin oxygenation measured by trancutaneous oximetry
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
Related trials for Diabetic Ulcers
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Robert M Levy, MD study director
Primus Pharmaceuticals, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vasculera in people with Diabetic Ulcers, run by Primus Pharmaceuticals 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 7 inclusion and 23 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: withdrawn, as of the sponsor's last update on 19 Apr 2024. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of healing of diabetic ulcers measured by ulcer size (time frame: 4 months). 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 19 Apr 2024.