Venous Leg UlcerNCT04901013
Clinical Study Of Affinity Versus SOC In The Management Of VLUs
A study testing Affinity in people with Venous Leg Ulcer, run by Organogenesis at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Affinity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ulcers of venous origin, as clinically determined by clinical signs and symptoms (e.g. hyperpigmentation of the surrounding skin, history of swelling, varicosities, lipodermatosclerosis and/or dermatitis) or other assessments (e.g. venous reflux test).
- Venous insufficiency ulcers, of at least 1-month duration, which have not adequately responded to conventional ulcer therapy
- Venous insufficiency ulcers between 2 cm2 and 80 cm2
- Partial- or full-thickness VLU, including ulcers with tissue damage that extends through the epidermis and into the upper epidermis (papillary dermis), or into the deep dermis (reticular dermis) but not through muscle, tendon, capsule, or into bone.
- Subjects are between 18 and 85 years of age.
- IRB approved Informed Consent Form is signed before screening and treatment.
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- Subject is expected to be available for 24 week follow-up
- Females of child-bearing potential must be practicing an acceptable means of birth control as determined by the investigator.
- Subjects with bilateral ulcers may be enrolled.
Who cannot join
- Ankle Brachial Index (ABI) of <0.65
- Venous insufficiency ulcers less than 2cm2 or greater than 80cm2
- Vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases
- Clinically significant medical conditions which would impair wound healing, as determined by the investigator, including renal, hepatic, hematologic, neurologic or immune disease
- Signs and symptoms of infection, cellulitis, osteomyelitis
- Necrotic or avascular ulcer beds
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- Ulcer with exposed bone, tendon or fascia
- Subjects receiving hemodialysis or have uncontrolled diabetes
- Subjects who are currently receiving or have received at any time within one month prior to entry into the study, corticosteroids (>15 mg/day), immunosuppressive agents, radiation therapy, or chemotherapy. Anticipated use of the above agents will exclude subjects from entry into the study.
- Subjects enrolled in other wound drug investigational studies within the past three months, or device studies within the past 30 days.
- Subject is pregnant or breast feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
ILD Research
Carlsbad, California, 92009
Eric Martinez, eric@ildresearch.com
Dean Vayser, DPM
About this study
Official title: A Prospective, Multicenter, Randomized, Controlled Clinical Study Of Affinity Versus SOC In The Management Of VLUs
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.
Read the detailed description
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.
- Conditions
- Venous Leg Ulcer
- Being tested
- Affinity
- Keywords
- VLU, Chronic Venous Leg Ulcer, Non-healing VLU
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AffinityOther
Affinity is an aseptically processed, hypothermically stored fresh allograft with viable cells, growth factors/cytokines, and extracellular matrix (ECM).
| Study group | Role | What they receive |
|---|---|---|
| Affinity plus SOC | Active comparator | 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 Receives: Other: Affinity |
| Standard of Care (SOC) | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Secondary outcomes (5)
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
Measured: 12 weeks
Greater than 40% wound closure at week 4 from baseline
Proportion of subjects achieving ≥ 40% wound closure at Week 4 from baseline
Measured: 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
Measured: 24 weeks
Incidence of ulcer recurrence
Number of recurrent ulcers
Measured: 24 weeks
Mean number of ulcer free days
Average number of ulcer free days
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start14 Jun 2021
- Primary completionMar 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine McLennan, Study director, Organogenesis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901013
- Sponsor's protocol ID
- 20-VLU-003-AFF
- Status last verified
- Sep 2021
- First submitted
- 20 May 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Controlled Clinical Study Of Affinity Versus SOC In The Management Of VLUs
- ClinicalTrials.gov ID
- NCT04901013
- Acronym / sponsor ID
- 20-VLU-003-AFF
- Conditions
- Venous Leg Ulcer
- Keywords
- VLU, Chronic Venous Leg Ulcer, Non-healing VLU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Affinity plus SOC | Active comparator | Other: AffinityAffinity 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 |
| Standard of Care (SOC) | No 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ulcers of venous origin, as clinically determined by clinical signs and symptoms (e.g. hyperpigmentation of the surrounding skin, history of swelling, varicosities, lipodermatosclerosis and/or dermatitis) or other assessments (e.g. venous reflux test).
- Venous insufficiency ulcers, of at least 1-month duration, which have not adequately responded to conventional ulcer therapy
- Venous insufficiency ulcers between 2 cm2 and 80 cm2
- Partial- or full-thickness VLU, including ulcers with tissue damage that extends through the epidermis and into the upper epidermis (papillary dermis), or into the deep dermis (reticular dermis) but not through muscle, tendon, capsule, or into bone.
- Subjects are between 18 and 85 years of age.
Key exclusion criteria (11 listed)
- Ankle Brachial Index (ABI) of <0.65
- Venous insufficiency ulcers less than 2cm2 or greater than 80cm2
- Vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases
- Clinically significant medical conditions which would impair wound healing, as determined by the investigator, including renal, hepatic, hematologic, neurologic or immune disease
- Signs and symptoms of infection, cellulitis, osteomyelitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AffinityAffinity is an aseptically processed, hypothermically stored fresh allograft with viable cells, growth factors/cytokines, and extracellular matrix (ECM). | Other | Affinity plus SOC |
Primary outcome
Length of time that a wound achieves complete wound closure (CWC)
Time frame: 24 weeks
Duration (number of days) to achieve CWC from baseline to week 24 assessed between both groups
5 secondary outcomes
Length of time that a wound achieves complete wound closure (CWC)
Time frame: 12 weeks
Greater than 40% wound closure at week 4 from baseline
Time frame: 4 weeks
VLU improvement by or on End of Study (EOS) from baseline
Time frame: 24 weeks
Incidence of ulcer recurrence
Time frame: 24 weeks
Mean number of ulcer free days
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine McLennan study director
Organogenesis Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Affinity in people with Venous Leg Ulcer, run by Organogenesis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Galen Hale ((205) 541-9682, GHale@organo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of time that a wound achieves complete wound closure (CWC) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.