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Cell Therapy

OrCel for Venous Ulcers

N/A
Waitlist Available
Research Sponsored by Ortec International
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with chronic venous insufficiency
Ulcer size between 2 and 20 sq cm, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial showed that OrCel is effective and safe in the treatment of venous ulcers.

Who is the study for?
This trial is for adults aged 18-85 with chronic venous insufficiency and leg ulcers between 2 and 20 sq cm that have persisted for at least a month. Participants must have an ankle-brachial index over 0.7, indicating good blood flow in the legs. Those with infected ulcers, significant wound healing during screening, uncontrolled diabetes, malnutrition or recent use of certain medications cannot join.Check my eligibility
What is being tested?
The study tests OrCel's effectiveness alongside standard compression therapy against compression therapy alone in treating venous ulcers. Over a period of 12 weeks, patients' ulcer healing is monitored; those who heal continue to be observed for another three months to check the persistence of healing.See study design
What are the potential side effects?
While specific side effects are not listed here, common concerns may include skin irritation at the treatment site, potential allergic reactions to OrCel components or increased risk of infection due to compromised skin integrity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with chronic venous insufficiency.
Select...
My ulcer is between 2 and 20 square centimeters in size.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Investigator Assessment of wound healing
Secondary outcome measures
Photographic assessment of wound healing
Planimetric assessment of wound healing

Find a Location

Who is running the clinical trial?

Ortec InternationalLead Sponsor
2 Previous Clinical Trials
130 Total Patients Enrolled
1 Trials studying Leg Ulcer
130 Patients Enrolled for Leg Ulcer

Media Library

OrCel (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00270972 — N/A
Leg Ulcer Research Study Groups:
Leg Ulcer Clinical Trial 2023: OrCel Highlights & Side Effects. Trial Name: NCT00270972 — N/A
OrCel (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00270972 — N/A

Frequently Asked Questions

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

How many venues are involved with conducting this clinical trial?

"Qualifying patients can pursue treatment at 10 distinct facilities, such as St Luke's Roosevelt in New york, Southside Hospital in Bay Shore, and Center for Advanced Wound Care in Reading."

Answered by AI

Are there any vacancies for participation in this experimental research?

"The data hosted on clinicaltrials.gov reveals that this trial is no longer actively recruiting patients, with the initial posting made back in September 1st 2005 and last update recorded as June 2nd 2006. Despite this study being inactive for recruitment, 372 other trials are presently seeking volunteers to take part."

Answered by AI

Who is qualified to take part in this trial?

"This clinical trial is in need of 60 individuals who suffer from venous insufficiency, aged 18 to 85. The key requirements for potential participants include: a leg ulcer that has been present for at least one month, an Ankle-Brachial Index (ABI) score of greater than 0.7, any race and gender between the previously stated age range, as well as an ulcer size of 2 - 20 square centimetres inclusive."

Answered by AI

Does this trial encompass participants who are below octogenarian age?

"According to the study's parameters, individuals who wish to join must be between 18 and 85 years of age. Additionally, there are 54 trials specifically for people below 18 and 331 dedicated towards seniors over 65."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
The Evaluation of OrCel for the Treatment of Venous Ulcers
2005. "The Evaluation of OrCel for the Treatment of Venous Ulcers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00270972.
~3 spots leftby Apr 2025
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