Olivamine-containing Products in the Management of Patients With Nonhealing Lower Extremity Ulcers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by De La Salle University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Pinnaclife Inc.
Information provided by (Responsible Party):
Michael M. Lawenko MD, FPCS, De La Salle University Medical Center
ClinicalTrials.gov Identifier:
NCT01657318
First received: August 2, 2012
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Ulcer
Skin Ulcer
Leg Ulcer
Diabetic Foot
Other: Olivamine containing wound care products

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by De La Salle University Medical Center:

Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chronic Wound Group
Treatment with Olivamine containing wound care products
Other: Olivamine containing wound care products
Continuous wound care with Olivamine containing products until wound closure. Intake of dietary supplement of 1 capsule for 60 days.
Other Names:
  • Olivamine Antiseptic Cleanser
  • Olivamine Cleansing Lotion
  • Olivamine Skin Restore Cream
  • Olivamine Wound Hydrogel
  • Miracle Olivamine Essential Dietary Supplement

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657318

Contacts
Contact: Michael M Lawenko, MD, FPCS 6329883100 ext 1090 mikelawenko@dlshsi.edu.ph
Contact: Melchor V Frias, MD 6329883100 ext 1388 mvgfrias@yahoo.com

Locations
Philippines
De La Salle University Medical Center Not yet recruiting
Dasmarinas City, Cavite, Philippines, 4114
Contact: Michael M. Lawenko, MD, FPCS    6329883100 ext 1090    mmlawenko@dlshsi.edu.ph   
Principal Investigator: Michael M. Lawenko, MD, FPCS         
Sub-Investigator: Renato CA Ocampo, MD, FPCS         
Sub-Investigator: Rey-An Garcia, MD         
Sub-Investigator: Marwin Emerson Matic, MD, FPCS         
Sub-Investigator: Melissa Robrigado, MD         
Sub-Investigator: Arvin John Ilagan, MD         
Sponsors and Collaborators
De La Salle University Medical Center
Pinnaclife Inc.
Investigators
Principal Investigator: Michael M Lawenko, MD, FPCS De La Salle University Medical Center
Study Chair: Melchor V. Frias, MD De La Salle Health Sciences Institute
Study Director: Renato CA Ocampe, MD, FPCS De La Salle University Medical Center
  More Information

No publications provided

Responsible Party: Michael M. Lawenko MD, FPCS, Assistant Professor, De La Salle University Medical Center
ClinicalTrials.gov Identifier: NCT01657318     History of Changes
Other Study ID Numbers: AKMRC-12-004
Study First Received: August 2, 2012
Last Updated: August 3, 2012
Health Authority: Philippines: Ethics Committee

Keywords provided by De La Salle University Medical Center:
diabetic foot
leg ulcer

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Leg Ulcer
Skin Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on September 18, 2014