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Affinity plus SOC for Venous Leg Ulcer

N/A
Waitlist Available
Research Sponsored by Organogenesis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Venous insufficiency ulcers, of at least 1-month duration, which have not adequately responded to conventional ulcer therapy
Subjects with bilateral ulcers may be enrolled.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

This trial compares Affinity, a new treatment, to standard of care for venous leg ulcers. Ulcers must be greater than 4 weeks old and have not responded to other treatments.

Eligible Conditions
  • Venous Leg Ulcer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have open sores on your legs due to poor blood flow that have not healed with standard care for at least a month.
Select...
People with sores on both sides of their body can participate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Greater than 40% wound closure at week 4 from baseline
Incidence of ulcer recurrence
Length of time that a wound achieves complete wound closure (CWC)
+2 more

Trial Design

2Treatment groups
Active Control
Group I: Standard of Care (SOC)Active Control1 Intervention
Standard of Care (SOC) includes, but is not limited to, surgical debridement, aggressive infection management, offloading, and maintenance of appropriate cleansing at the time of each dressing change.
Group II: Affinity plus SOCActive Control1 Intervention
Affinity is an aseptically processed, hypothermically stored fresh allograft with viable cells, growth factors/cytokines, and extracellular matrix (ECM). Affinity is human allograft tissue that is regulated as a Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) as defined by FDA 21 CFR Part 1271. Affinity may be applied as a wound covering to partial- and full-thickness acute and chronic wounds

Find a Location

Who is running the clinical trial?

OrganogenesisLead Sponsor
35 Previous Clinical Trials
4,070 Total Patients Enrolled
Christine McLennanStudy DirectorOrganogenesis Inc.
1 Previous Clinical Trials
200 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor have a call for participants?

"Affirmative. Clinicaltrials.gov provides evidence that this medical trial is currently open to patients, having first been published on June 14th 2021 and edited most recently on September 7th 2021. The study requires 200 participants at 1 clinical site."

Answered by AI

Are there opportunities for me to be part of this clinical trial?

"The prerequisites for participating in this trial are having a venous leg ulcer (VLU) and being between 18-85 years old. Approximately 200 applicants are required to complete the study."

Answered by AI

How many participants is this research project accepting?

"Affirmative. Per data hosted on clinicaltrials.gov, this medical investigation is actively recruiting participants which it initially posted to the website on June 14th 2021 and most recently updated September 7th of the same year. 200 people are being enlisted from a single location for participation in the trial."

Answered by AI

Are applicants above a certain age precluded from participating in this experiment?

"As indicated by the criteria for enrollment, this trial is open to individuals between 18 and 85. Separately, there are 4 trials available for those under 18 years of age and 67 studies catered toward participants over 65."

Answered by AI
~53 spots leftby Mar 2025