Suspended

A Multi-Center, Prospective, Cohort Trial Comparing the Effectiveness of AutoloGel Therapy to Usual and Customary Care in Venous Leg Ulcers

What is being tested

AutoloGel

Device

Who is being recruted

Cardiovascular Diseases+5

+ Leg Ulcer

+ Skin Diseases

Over 18 Years

+18 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: October 2013

See protocol details

Summary

Principal SponsorCytomedix

Last updated: October 21, 2016

Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2013

Actual date on which the first participant was enrolled.

Recurrence of ulcers in the leg is common; two-thirds of patients are likely to experience recurring ulcers after the first ulcer. While treatment of the underlying venous disease, depending on the mode of treatment, can lower the recurrence rate in many patients, it does not affect recurrence. AutoloGel is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. The aim of this trial is to demonstrate the effectiveness, measured as complete wound healing, in a prospective, open-label trial in which venous leg ulcers will be treated using AutoloGel and standard of care and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care

NCT01817543

Principal SponsorCytomedix

Last updated: October 21, 2016

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

2 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesLeg UlcerSkin DiseasesSkin UlcerVaricose VeinsVascular DiseasesSkin and Connective Tissue DiseasesVaricose Ulcer

Criteria

9 inclusion criteria required to participate

>= 18 years of age

Debrided ulcer size between 2 cm2 and 200 cm2

Demonstrated adequate compression regimen

Duration >= 1 month at first visit

Show More Criteria

9 exclusion criteria prevent from participating

Any malignancy other than non-melanoma skin cancer

Hemoglobin of less than 10.5 g/dL

Plasma Platelet count of less than 100 x 109/L

Presence of another wound that is concurrently treated and might interfere with treatment of index wound by AutoloGel

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Subjects will be treated on average twice a week for the first 2 weeks, and then, once a week thereafter while under active treatment, but actual frequency of treatment will be determined by the treating physician. All subjects will receive Autologel treatment

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Arcadia, United StatesOpen in Google Maps

HyperBarxs at Northside Forsyth

Cumming, United States

Suspended2 Study Centers