UlcerNCT01657318
Olivamine-containing Products in the Management of Patients With Nonhealing Lower Extremity Ulcers
An observational study of Ulcer and Skin Ulcer, run by De La Salle University Medical Center at 1 site in Philippines.
Trial summary
In this study, the investigators hypothesize that the use of olivamine-containing products in the management of patients with compromised nonhealing lower extremity ulcers is feasible in the Philippine setting. It will result in complete ulcer healing or wound closure after 16 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcer, Skin Ulcer, Leg Ulcer
- What is being tested?
- Olivamine containing wound care products
- Type of treatment
- Pill or oral medicine
- How many people
- 5 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 Sep 2012to 15 Feb 2013
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential study subjects will be patients who are 18 years or older, has confirmed with the informed consent. He/she has a non-healing lower extremity ulcers compromised due to underlying factors such as peripheral arterial disease, diabetes, venous insufficiency, and pressure. The ulcer must be between 1.0 cm2 and 10 cm2.
Who may be able to join
- Patient is 18 years old or older.
- Patient has a diagnosis of arterial, diabetic foot, venous insufficiency, or pressure ulcer or surgical and traumatic wound.
- Patient's target study ulcer/wound is a lower extremity full thickness ulcer/wound not involving tendon, capsule, or bone.
- Patient's target study ulcer/wound and is ≥1.0 cm2 and ≤ 10.0 cm2 in size at the day of initial consult.
- Study ulcer/wound has been present for greater than 6 weeks prior to initial consult.
- Patients with Charcot foot deformities can be entered so long as the Charcot disease is not active, and the ulcer can be offloaded by an orthotic device.
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- The patient has adequate circulation to the lower extremity as evidenced by an ABI (measured by Doppler) of ≥ 0.7. If the patient has non-compressible leg arteries, as documented by an ABI >1.3, then the patient must have a Toe-Brachial Index be > 0.6, or a toe pressure >50 mm Hg.
- Patient must have adequate in-home support to comply with all protocol-mandated visits and procedures, offloading or pressure redistribution as required, and proper application of study products and wound care regimen.
- Patient or his/her legal representative has read and signed the Institutional Review Board-approved Informed Consent form before Screening.
Who cannot join
- An ulcer/wound that is ≥10.0 cm2 and ≤ 1.0 cm2 in size at the day of initial consult is not eligible for this study.
- Patient has clinical evidence of gangrene or infection on any part of the affected foot.
- The patient is judged by the investigator or study staff to be unable or unlikely to comply with daily wound care instructions, or study visits.
- Patient has clinical evidence of active sepsis or invasive infection (e.g., cellulitis, osteomyelitis).
- Patient has muscle, tendon, or bone exposure in any ulcer bed.
- Patient has known sensitivity or allergy to any component of the study product - Olivamine10.
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- Patient has one or more medical condition(s), including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the - Investigator would make the patient an inappropriate candidate for this wound healing study.
- Patient has a malignant disease (other than squamous or basal cell carcinoma of the skin) not in remission for five years or more.
- Patient has known alcohol or drug abuse.
- Patient has a hematocrit greater than 60% or less than 27%.
- Patient's diabetes is under poor control as manifested by HbA1c of >10.0%.
- Patient has clinically significant renal insufficiency or creatinine greater than 2.0 mg/dL.
- Patient has chronic liver disease or clinically significant liver enzyme abnormality as evidenced by elevated AST, ALT, or bilirubin greater than 1.5 times upper limit of normal (ULN).
- Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, or is anticipated to require such agents during the course of the study.
- Patient is using tobacco, or is exposed to a current smoker in their household. Patients may participate in the study if they have not used tobacco for 3 months and have not had a smoker in their household for 3 months.
- Patient is using any form of nicotine including nicotine patches, gums, or sprays.
- Patient has Acquired Immunodeficiency Syndrome (AIDS) or is known to be infected with Human Immunodeficiency Virus (HIV).
Trial locations and contacts
1 site in 1 country.
Philippines1 site
De La Salle University Medical Center
Dasmariñas, Cavite, 4114
About this study
Official title: A Prospective Observational Study on the Use of a Olivamine-containing Products in the Management of Patients With Compromised Nonhealing Lower Extremity Ulcers
In this study, the investigators hypothesize that the use of olivamine-containing products in the management of patients with compromised nonhealing lower extremity ulcers is feasible in the Philippine setting. It will result in complete ulcer healing or wound closure after 16 weeks.
Read the detailed description
The specific aim of this study is to assess the feasibility of using olivamine-containing products in the management of patients with compromised nonhealing lower extremity ulcers in the Philippines. The primary endpoint of which is to evaluate the efficacy of Olivamine on healing of chronic lower extremity ulcers which will be assessed by rate of change in ulcer size (wound healing trajectory) and proportion with complete ulcer healing (wound closure) at 4, 8, 16 and 16 weeks compared to baseline, week 0.
- Conditions
- Ulcer, Skin Ulcer, Leg Ulcer, Diabetic Foot
- Being tested
- Olivamine containing wound care products
- Keywords
- diabetic foot, leg ulcer
- Medical subject headings
- Ulcer, Skin Ulcer, Leg Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olivamine containing wound care productsOther
Also called Olivamine Antiseptic Cleanser, Olivamine Cleansing Lotion, Olivamine Skin Restore Cream, Olivamine Wound Hydrogel
Continuous wound care with Olivamine containing products until wound closure. Intake of dietary supplement of 1 capsule for 60 days.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Wound Group | Treatment with Olivamine containing wound care products Receives: Other: Olivamine containing wound care products |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study start1 Sep 2012
- Primary completion30 Jan 2013
- Study completion15 Feb 2013
Why it stopped: challenges encountered in the methodology and concerns with the gold standard of treatment
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- De La Salle University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pinnaclife Inc.
- Responsible party
- Principal investigator, Michael M. Lawenko MD, FPCS, De La Salle University Medical Center
- Investigators
- Michael M Lawenko, MD, FPCS, Principal investigator, De La Salle University Medical CenterMelchor V. Frias, MD, Study chair, De La Salle Health Sciences InstituteRenato CA Ocampe, MD, FPCS, Study director, De La Salle University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657318
- Sponsor's protocol ID
- AKMRC-12-004
- Status last verified
- Aug 2018
- First submitted
- 2 Aug 2012
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study on the Use of a Olivamine-containing Products in the Management of Patients With Compromised Nonhealing Lower Extremity Ulcers
- ClinicalTrials.gov ID
- NCT01657318
- Acronym / sponsor ID
- AKMRC-12-004
- Conditions
- Ulcer, Skin Ulcer, Leg Ulcer, Diabetic Foot
- Keywords
- diabetic foot, leg ulcer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: challenges encountered in the methodology and concerns with the gold standard of treatment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- De La Salle University Medical CenterUniversity, hospital or other
- Collaborators
- Pinnaclife Inc.
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 30 Jan 2013 (actual)
- Study completion
- 15 Feb 2013 (actual)
- First posted
- 6 Aug 2012 (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.
In this study, the investigators hypothesize that the use of olivamine-containing products in the management of patients with compromised nonhealing lower extremity ulcers is feasible in the Philippine setting. It will result in complete ulcer healing or wound closure after 16 weeks.
Detailed description
The specific aim of this study is to assess the feasibility of using olivamine-containing products in the management of patients with compromised nonhealing lower extremity ulcers in the Philippines. The primary endpoint of which is to evaluate the efficacy of Olivamine on healing of chronic lower extremity ulcers which will be assessed by rate of change in ulcer size (wound healing trajectory) and proportion with complete ulcer healing (wound closure) at 4, 8, 16 and 16 weeks compared to baseline, week 0.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Wound Group | – | Other: Olivamine containing wound care productsTreatment with Olivamine containing wound care products |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential study subjects will be patients who are 18 years or older, has confirmed with the informed consent. He/she has a non-healing lower extremity ulcers compromised due to underlying factors such as peripheral arterial disease, diabetes, venous insufficiency, and pressure. The ulcer must be between 1.0 cm2 and 10 cm2.
Key inclusion criteria (9 listed)
- Patient is 18 years old or older.
- Patient has a diagnosis of arterial, diabetic foot, venous insufficiency, or pressure ulcer or surgical and traumatic wound.
- Patient's target study ulcer/wound is a lower extremity full thickness ulcer/wound not involving tendon, capsule, or bone.
- Patient's target study ulcer/wound and is ≥1.0 cm2 and ≤ 10.0 cm2 in size at the day of initial consult.
- Study ulcer/wound has been present for greater than 6 weeks prior to initial consult.
Key exclusion criteria (17 listed)
- An ulcer/wound that is ≥10.0 cm2 and ≤ 1.0 cm2 in size at the day of initial consult is not eligible for this study.
- Patient has clinical evidence of gangrene or infection on any part of the affected foot.
- The patient is judged by the investigator or study staff to be unable or unlikely to comply with daily wound care instructions, or study visits.
- Patient has clinical evidence of active sepsis or invasive infection (e.g., cellulitis, osteomyelitis).
- Patient has muscle, tendon, or bone exposure in any ulcer bed.
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 |
|---|---|---|
| Olivamine containing wound care productsAlso: Olivamine Antiseptic Cleanser, Olivamine Cleansing Lotion, Olivamine Skin Restore Cream, Olivamine Wound HydrogelContinuous wound care with Olivamine containing products until wound closure. Intake of dietary supplement of 1 capsule for 60 days. | Other | Chronic Wound Group |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: challenges encountered in the methodology and concerns with the gold standard of treatment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
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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.
Michael M Lawenko, MD, FPCS principal investigator
De La Salle University Medical Center
Melchor V. Frias, MD study chair
De La Salle Health Sciences Institute
Renato CA Ocampe, MD, FPCS study director
De La Salle University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcer and Skin Ulcer, run by De La Salle University Medical Center at 1 site in Philippines.
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 17 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 14 Aug 2018. 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 Philippines. 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. 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 stopped early (reason given: challenges encountered in the methodology and concerns with the gold standard of treatment). 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.
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 14 Aug 2018.