WithdrawnPhase 3

Evaluate the Noninferiority of Medicines Treating Uninfected Pressure Ulcers.

Brazil0Started 2015-01

Plain-language summary

This is a Clinical study Phase III, Prospective, Randomized, Controlled, Double-blind, Multicenter, National, Non-inferiority. Its purpose is to determine the noninferiority in efficacy of an investigational product in relation to the product available in the market intended of treating pressure ulcers.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Both sexes; * Aged ≥ 18 years and ≤ 80 years; * Patients hospitalized; * Patients with leg ulcers in the sacral region with presence of devitalized/ necrotic tissue indicating conservative debridement; * Understanding, agreement and signing the Informed Consent Form (IFC), and the Authorization Term for the Image Use for publication of results Exclusion Criteria: * Infected ulcers; * Limited ulcers; * Ulcers with indication for surgical debridement ; * Periostitis ; * Obesity II( BMI ≥ 35 ) ; * Severe malnutrition ( BMI \< 16 ) * Hemoglobin (HbA1c ) above the upper limit of normal (ULN ) ; * Coagulation Factor twice the ULN ; * Patients with pulmonary emphysema and / or Chronic Obstructive Pulmonary Disease (COPD) ; * Collagen diseases; * Psychiatric illnesses; * Patients using cytotoxic agents ; * Oncology patients under palliative care ; * Outpatients ; * Signs of limb ischemia ; * Urinary incontinence uncontrolled; * Fecal incontinence; * Diarrhea that in the opinion of the investigator , compromise the process of debridement; * Known allergy from the components of the formulas; * Pregnancy ; * Breastfeeding ; * Local and concomitant use of medications and / or products in the lesion: tyrothricin , gramicidin , tetracycline , hexachlorophene , heavy metals ( mercury, silver) , iodine , potassium permanganate , hydrogen peroxide , soap, detergent.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Devitalized tissue reduction.

Timeframe: A month.

Trial details

NCT IDNCT02004626

SponsorCristália Produtos Químicos Farmacêuticos Ltda.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-06

View on ClinicalTrials.gov More Pressure Ulcer trials