Clinical trial NCT01657318: Olivamine-containing Products in the Management of Patients With Nonhealing Lower Extremity Ulcers
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ulcer
Skin Ulcer
Leg Ulcer
Diabetic Foot
Keywords: diabetic foot
leg ulcer
Lead sponsor: De La Salle University Medical Center
Sponsor class: OTHER
Collaborators: name: Pinnaclife Inc.
First posted: 2012-08-06
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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 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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dasmariñas
country: Philippines
facility: De La Salle University Medical Center
state: Cavite
Study officials:
affiliation: De La Salle University Medical Center
name: Michael M Lawenko, MD, FPCS
role: PRINCIPAL_INVESTIGATOR
affiliation: De La Salle Health Sciences Institute
name: Melchor V. Frias, MD
role: STUDY_CHAIR
affiliation: De La Salle University Medical Center
name: Renato CA Ocampe, MD, FPCS
role: STUDY_DIRECTOR
References: