An interventional study of Affinity in Venous Leg Ulcer, sponsored by Organogenesis. Status unknown at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-09-08.
Sponsored by Organogenesis · Not applicable, Interventional, and Treatment
Among 155 studies in Varicose Ulcer with a site in United States — 33 open to participants now, 43 under way, 4 of them phase 3. Varicose Ulcer · United States.
Among the 155 studies in Varicose Ulcer with a site in United States, this one is the 23rd largest by planned enrollment of the 132 interventional ones that give a count, is one of 8 that started in 2021, is one of 79 with no phase, and was the 106th registered.
369 studies on the registry are indexed under Varicose Ulcer; 75 are open to participants now.
Browse Varicose Ulcer studies →33 of the 155 studies in Varicose Ulcer with a site in United States are open now. Recruiting first, the newest first:
W.L.Gore & Associates · Sites in United States
Ages 18+
NuScience Medical Biologics, LLC · Sites in United States
Ages 18+
BioLab Holdings · Sites in United States
Ages 18+
Capsicure, LLC · Sites in United States
Ages 18+
BioLab Holdings · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 50 Varicose Ulcer studies recruiting now, 40 (80%) set no upper age limit and 5 (10%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
155 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 19 · Phase 3 10 · Phase 4 15
First in 2000; this study’s year is marked. 8 started in 2021.
This study's planned enrollment of 200 is above the median of 60 across 309 interventional studies indexed under Varicose Ulcer.
Median enrollment 53 across the 132 interventional studies, 300 across the 23 observational. Of the 87 that completed or were terminated, 34 (39%) have results posted.
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109 of 155 have an industry lead sponsor. The 10 most frequent:
Organogenesis is the lead sponsor of 27 studies on the registry; 2 are open to participants now.
Organogenesis has 7 studies filed under Varicose Ulcer — fewer than ten, so there is no comparison to draw.
20 of the studies in Varicose Ulcer with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06568627Phase 3MediWound LtdA Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE) | 2026-12 |
| NCT06707103Phase 3TR TherapeuticsTissue Repair Gel in Venous Leg Ulcers in AU/US | 2026-12 |
| NCT06489028Phase 3RHEACELL GmbH & Co. KGAllogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III) | 2027-04 |
| NCT06697925Kerecis Ltd.Evaluating the Durability of Closure for Venous Leg Ulcers | 2026-11 |
| NCT06674980C5 BiomedicalClinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs | 2026-11-22 |
Add all 20 to your calendar (.ics) → With an account.
Among the 155 studies in Varicose Ulcer with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This prospective, multi-center, randomized, controlled clinical study compares Affinity® plus SOC to SOC alone in subjects with VLUs. Affinity® will be used along with standard of care on venous leg ulcers (VLUs) of greater than 4 weeks which have not adequately responded to conventional ulcer therapy.
Two hundred (200) subjects with a chronic VLU ranging in size from 2cm2 and 80 cm2 will be randomized 1:1 to either Affinity® and SOC or SOC alone following the 28 day screening period. Following screening and randomization, subjects shall be seen weekly for up to 24 weeks. For subjects that heal prior to week 24, a healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure.
Subjects that are randomized into the SOC group whose VLU has not healed by week 12 may be crossed over to receive Affinity® and followed for an additional 12-14 weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: Affinity
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.
Affinity is an aseptically processed, hypothermically stored fresh allograft with viable cells, growth factors/cytokines, and extracellular matrix (ECM).
Length of time that a wound achieves complete wound closure (CWC)
Duration (number of days) to achieve CWC from baseline to week 24 assessed between both groups
Time frame: 24 weeks
Length of time that a wound achieves complete wound closure (CWC)
Duration (number of days) to achieve CWC from baseline to week 12 assessed between both groups
Time frame: 12 weeks
Greater than 40% wound closure at week 4 from baseline
Proportion of subjects achieving ≥ 40% wound closure at Week 4 from baseline
Time frame: 4 weeks
VLU improvement by or on End of Study (EOS) from baseline
Defined by \>60% reduction in area, or \>60% reduction in depth, or \>75% reduction in volume
Time frame: 24 weeks
Incidence of ulcer recurrence
Number of recurrent ulcers
Time frame: 24 weeks
Mean number of ulcer free days
Average number of ulcer free days
Time frame: 24 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2021 (actual). Primary completion is estimated for Mar 2023, 21 months after the start.
Of 66 industry-sponsored interventional studies with no phase under Varicose Ulcer, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 37. This study's planned 21 months is close to that.
Counting every sponsor, half of 133 studies reached it within 28 months; a quarter within 13 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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