Venous Leg UlcersNCT07510412
Clinical Trial Evaluating NuShield® Plus Standard of Care (SOC) Versus Standard of Care (SOC) Alone in the Management of Non-Healing Venous Leg Ulcers (VLUs)
A study testing NuShield® in people with Venous Leg Ulcers, run by Organogenesis at 1 site in United States.
Trial summary
A Prospective, Multi-Center, Randomized Controlled Clinical Trial Evaluating NuShield® plus Standard of Care (SOC) versus Standard of Care (SOC) alone in the Management of Non-Healing Venous Leg Ulcers (VLUs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcers
- What is being tested?
- NuShield®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be at least 18 years of age or older.
- Index Ulcer must be of venous origin, as 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)
- The index ulcer must have been present for a minimum of 4 weeks
- The subject must have a study wound that falls within a specified size range
- If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the index ulcer.
- Index ulcer is located on the leg, below the knee and at or above the malleoli.
Show all 16Show fewer
- Partial or full-thickness index ulcer extending into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule.
- The subject must be willing and able to participate, understand, and sign the IRB approved informed consent process prior to any study procedures.
- Subjects agree to be compliant with all study requirements, including weekly study visits.
- Females of childbearing potential must use acceptable methods of contraception (birth control pills, barriers, or abstinence) for at least one month prior to randomization and for the duration of study participation. Males must be willing to use acceptable methods of birth control (barriers or abstinence) from randomization through study participation.
- Adequate circulation to the affected limb as documented by any of the following methods performed within 3 months prior to the first screening visit:
- TCOM > 30 mmHg
- ABI > 0.75
- SPP > 30mmHg
- As an alternative, Arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle on the extremity the index ulcer is located.
- Subject failed to adequately respond to conventional therapy
Who cannot join
- Index ulcer is of non-venous pathophysiology.
- Subjects unable to tolerate sharp debridement and standard compression therapy.
- If, at the opinion of the investigator, the index wound requires debridement necessitating surgery or enzymatic therapies.
- The surface area measurement of the index ulcer has reduced in size by a specified amount from the initial screening visit (SV1) to Visit 1/randomization visit
- Subjects receiving systemic steroids greater than 5 mg of Cortisone per day or equivalent.
- A subject who, in the opinion of the Investigator, has a clinically relevant medical condition which could impact subject safety, impair treatment effectiveness, or otherwise interfere with their ability to comply with study requirements.
Show all 15Show fewer
- Signs and symptoms of index ulcer infection, including but not limited to cellulitis or osteomyelitis (as evidenced by Investigator's exam or x-ray).
- Necrotic or avascular index ulcer beds.
- Index ulcer contains exposed muscle, tendon, bone, or joint capsule.
- Subjects receiving hemodialysis or having a creatinine level of > 3.0mg/dL within 6 months of randomization.
- Subjects with an HbA1c level of >12% within 3 months of randomization (if the subject is diabetic).
- Topical application of steroids to the index ulcer surface within one month of initial screening.
- Subjects who are currently receiving, or who previously received at any time within one month prior to screening, immunosuppressive agents (including inhaled corticosteroids and oral cortisone 5 mg or more daily), radiation therapy, or chemotherapy. Anticipated use of any of the above agents is considered exclusionary.
- Subjects who are pregnant or breast-feeding.
- Subjects with a history of poor compliance with medical treatment or who are unwilling or unable to adhere to the protocol requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cutting Edge Research
Pickerington, Ohio, 43113
About this study
Official title: A Prospective, Multi-Center, Randomized Controlled Clinical Trial Evaluating NuShield® Plus Standard of Care (SOC) Versus Standard of Care (SOC) Alone in the Management of Non-Healing Venous Leg Ulcers (VLUs)
A Prospective, Multi-Center, Randomized Controlled Clinical Trial Evaluating NuShield® plus Standard of Care (SOC) versus Standard of Care (SOC) alone in the Management of Non-Healing Venous Leg Ulcers (VLUs). The study is a prospective, multi-center, open label, RCT designed to collect subject outcome data on NuShield plus Standard of Care vs Standard of Care alone for the management of VLUs.
- Conditions
- Venous Leg Ulcers
- Being tested
- NuShield®
- Keywords
- VLU, Non- Healing Venous Leg Ulcers, Chronic Venous Leg Ulcers, Venous Leg Ulcers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuShield®Other
NuShield® is a dehydrated placental allograft
| Study group | Role | What they receive |
|---|---|---|
| NuShield® plus Standard of Care (SOC) | Experimental | Not described Receives: Other: NuShield® |
| Standard of Care (SOC) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects that obtain complete closure
The proportion of subjects that obtain complete closure. Complete closure is defined as full epithelialization of the wound with the absence of drainage and infection as well as visible epithelium on the wound surface.
Measured: 16 weeks
Secondary outcomes (3)
The proportion of subjects that obtain complete closure on or before 12 weeks of treatment
The proportion of subjects that obtain complete closure on or before 12 weeks of treatment. Complete closure is defined as full epithelialization of the wound with the absence of drainage and infection as well as visible epithelium on the wound surface
Measured: 12 weeks
Time to achieve complete wound closure of the index ulcer
Number of weeks to achieve complete wound closure
Measured: 16 weeks
Percentage wound area reduction
Percentage change from baseline wound area to final wound area
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start18 Mar 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcersStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Professional Education and Research Institute
- Responsible party
- Sponsor
- Investigators
- Maribel Riesco, Study director, Organogenesis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510412
- Sponsor's protocol ID
- 25-VLU-004-NUS
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 3 Apr 2026
- 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 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Randomized Controlled Clinical Trial Evaluating NuShield® Plus Standard of Care (SOC) Versus Standard of Care (SOC) Alone in the Management of Non-Healing Venous Leg Ulcers (VLUs)
- ClinicalTrials.gov ID
- NCT07510412
- Acronym / sponsor ID
- 25-VLU-004-NUS
- Conditions
- Venous Leg Ulcers
- Keywords
- VLU, Non- Healing Venous Leg Ulcers, Chronic Venous Leg Ulcers, Venous Leg Ulcers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Collaborators
- Professional Education and Research Institute
- Study start
- 18 Mar 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 3 Apr 2026 (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.
A Prospective, Multi-Center, Randomized Controlled Clinical Trial Evaluating NuShield® plus Standard of Care (SOC) versus Standard of Care (SOC) alone in the Management of Non-Healing Venous Leg Ulcers (VLUs). The study is a prospective, multi-center, open label, RCT designed to collect subject outcome data on NuShield plus Standard of Care vs Standard of Care alone for the management of VLUs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NuShield® plus Standard of Care (SOC) | Experimental | Other: NuShield® |
| Standard of Care (SOC) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subjects must be at least 18 years of age or older.
- Index Ulcer must be of venous origin, as 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)
- The index ulcer must have been present for a minimum of 4 weeks
- The subject must have a study wound that falls within a specified size range
- If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the index ulcer.
Key exclusion criteria (15 listed)
- Index ulcer is of non-venous pathophysiology.
- Subjects unable to tolerate sharp debridement and standard compression therapy.
- If, at the opinion of the investigator, the index wound requires debridement necessitating surgery or enzymatic therapies.
- The surface area measurement of the index ulcer has reduced in size by a specified amount from the initial screening visit (SV1) to Visit 1/randomization visit
- Subjects receiving systemic steroids greater than 5 mg of Cortisone per day or equivalent.
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 |
|---|---|---|
| NuShield®NuShield® is a dehydrated placental allograft | Other | NuShield® plus Standard of Care (SOC) |
Primary outcome
The proportion of subjects that obtain complete closure
Time frame: 16 weeks
The proportion of subjects that obtain complete closure. Complete closure is defined as full epithelialization of the wound with the absence of drainage and infection as well as visible epithelium on the wound surface.
3 secondary outcomes
The proportion of subjects that obtain complete closure on or before 12 weeks of treatment
Time frame: 12 weeks
Time to achieve complete wound closure of the index ulcer
Time frame: 16 weeks
Percentage wound area reduction
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Venous Leg Ulcers
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
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.
Maribel Riesco study director
Organogenesis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NuShield® in people with Venous Leg Ulcers, 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 16 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 3 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alex Erb (570-560-1269, aerb@organo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects that obtain complete closure (time frame: 16 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 3 Apr 2026.