NCT01657318

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

A Prospective Observational Study on the Use of a Olivamine-containing Products in the Management of Patients With Compromised Nonhealing Lower Extremity Ulcers

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: De La Salle University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcer
• Skin Ulcer
• Leg Ulcer
• Diabetic Foot

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-01-30
• Completion: 2013-02-15
• First posted: 2012-08-06
• Last updated: 2018-08-14

Locations

1 site across 1 country: Philippines