Venous Leg UlcerNCT03629236
Study to Evaluate Safety and Efficacy of GrafixPL for the Treatment of Venous Leg Ulcers
A study testing GrafixPL in people with Venous Leg Ulcer, run by Osiris Therapeutics at 2 sites in United States.
Trial summary
A Multicenter, Prospective, Randomized, Open-Label Study with a Crossover Extension Option to Evaluate the Safety and Efficacy of GrafixPL for the Treatment of Chronic VLUs Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- GrafixPL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jun 2018to 24 Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older, as of the date of screening
- An Index Ulcer that is chronic (defined as present for > 4 weeks, but not present for more than 52 weeks at Screening Visit 1)
- Index Ulcer is located on the leg, below the knee and above the malleoli (ulcer may be inclusive of the malleoli)
- The Index Ulcer is between 1 cm2 and 25 cm2, inclusive, at the Screening and Baseline Visits. The longest dimension of the index ulcer cannot exceed 10 cm at the Baseline Visit.
- The Index Ulcer has had compression therapy for > 2 weeks at Screening Visit 1
- The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
- Patient has adequate circulation to the foot, as documented up to 14 days prior to Screening Visit 1
- Confirmed diagnosis of venous insufficiency, as documented up to 30 days prior to enrollment
Who cannot join
- Index Ulcer is of non-venous pathophysiology
- Gangrene is present on any part of the affected limb
- Patient is unable to tolerate standard compression therapy
- Glycated hemoglobin A1c (HbA1c) level of > 14% in any patient with type 1 or type 2 diabetes mellitus, as documented up to 14 days prior to Screening Visit 1
- Patient is receiving intravenous (IV) corticosteroids, immunosuppressive or cytotoxic agents at any time during the screening period
- Patient has an ulcer within 5 cm of the Index Ulcer identified for study consideration
Show all 18Show fewer
- Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
- Current evidence of infection at the Index Ulcer, including cellulitis and/or pus drainage from the ulcer site at the time of Screening and Baseline Visits
- Evidence of osteomyelitis at the time of Screening and Baseline Visits
- Patient has active malignancy other than non-melanoma skin cancer
- Patient's Index Ulcer has decreased by ≥ 30% between Screening Visit 1 and the Baseline Visit during the screening period
- Patient has untreated alcohol or substance abuse at the time of Screening Visit 1
- Pregnant women and women who are breastfeeding
- Patient is currently enrolled in or has participated in another investigational device, drug, or biological trial within 30 days prior to Screening Visit 1
- Patient has had within 14 days of Screening Visit 1, or is currently undergoing, or is planning for ulcer treatments with growth factors, living skin, dermal substitutes or other advanced biological therapies
- Patient is an employee, or an immediate family member of an employee, of the sponsor company or site research staff conducting the study
- Patients who have already been randomized in Protocol 360 at any center may not be considered for screening or for re-entry into the trial at any center, even after the End of Treatment Study Visit
- Patients with a history of poor compliance, or an unwillingness or inability to adhere to the requirements of the protocol
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Integral Clinical Trial Solutions
Doral, Florida, 33126
SSH
Weymouth, Massachusetts, 02189
About this study
Official title: A Multicenter, Prospective, Randomized, Open-Label Study With a Crossover Extension Option to Evaluate the Safety and Efficacy of GrafixPL for the Treatment of Chronic Venous Leg Ulcers
A Multicenter, Prospective, Randomized, Open-Label Study with a Crossover Extension Option to Evaluate the Safety and Efficacy of GrafixPL for the Treatment of Chronic VLUs
- Conditions
- Venous Leg Ulcer
- Being tested
- GrafixPL, Control
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrafixPLOther
Also called Tissue Allograft
Debridement, GrafixPL application, dressing application, standard compression therapy
ControlOther
Debridement, dressing application, standard compression therapy
| Study group | Role | What they receive |
|---|---|---|
| GrafixPL | Experimental | Not described Receives: Other: GrafixPL |
| Control | Active comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete closure of the index ulcer
Measured: Up to 84 days after the Baseline Visit
Secondary outcomes (5)
Time to initial ulcer closure
Measured: Up to 84 days after the Baseline Visit
Measurement of percent area reduction in ulcers that do not achieve closure
Measured: 84 days after the Baseline Visit
Proportion of patients with ulcer reoccurrence in Follow-Up Phase
Measured: Up to 6 months after initial ulcer closure
Proportion of patients in the Crossover Extension Treatment Phase who achieve complete ulcer closure
Measured: Up to 91 days after initial Treatment Phase
Time to initial ulcer among patients in the Crossover Extension Treatment Phase
Measured: Up to 91 days after initial Treatment Phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start27 Jun 2018
- Primary completion24 Jun 2021
- Study completion24 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 (actual)
Sponsor and investigators
- Lead sponsor
- Osiris Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaideep Banerjee, PHD, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629236
- Sponsor's protocol ID
- Osiris Protocol 360
- Status last verified
- Mar 2022
- First submitted
- 18 May 2018
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dhillon Y, Levine L, Tovmassian G, Reyzelman A, Perez-Clavijo F, Wodie F, Cazzell S, Grossman A, Robinson L, Sigal F, Kirsner RS, Vartivarian M, Saunders M, Banerjee J. A Multicenter, Randomized, Controlled, Clinical Trial Evaluating a Lyopreserved Amniotic Membrane in the Treatment of Venous Leg Ulcers. Health Sci Rep. 2025 May 4;8(5):e70819. doi: 10.1002/hsr2.70819. eCollection 2025 May.
PubMed 40330756
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Open-Label Study With a Crossover Extension Option to Evaluate the Safety and Efficacy of GrafixPL for the Treatment of Chronic Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT03629236
- Acronym / sponsor ID
- Osiris Protocol 360
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Osiris TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 24 Jun 2021 (actual)
- Study completion
- 24 Jun 2021 (actual)
- First posted
- 14 Aug 2018 (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 Multicenter, Prospective, Randomized, Open-Label Study with a Crossover Extension Option to Evaluate the Safety and Efficacy of GrafixPL for the Treatment of Chronic VLUs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GrafixPL | Experimental | Other: GrafixPL |
| Control | Active comparator | Other: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years or older, as of the date of screening
- An Index Ulcer that is chronic (defined as present for > 4 weeks, but not present for more than 52 weeks at Screening Visit 1)
- Index Ulcer is located on the leg, below the knee and above the malleoli (ulcer may be inclusive of the malleoli)
- The Index Ulcer is between 1 cm2 and 25 cm2, inclusive, at the Screening and Baseline Visits. The longest dimension of the index ulcer cannot exceed 10 cm at the Baseline Visit.
- The Index Ulcer has had compression therapy for > 2 weeks at Screening Visit 1
Key exclusion criteria (18 listed)
- Index Ulcer is of non-venous pathophysiology
- Gangrene is present on any part of the affected limb
- Patient is unable to tolerate standard compression therapy
- Glycated hemoglobin A1c (HbA1c) level of > 14% in any patient with type 1 or type 2 diabetes mellitus, as documented up to 14 days prior to Screening Visit 1
- Patient is receiving intravenous (IV) corticosteroids, immunosuppressive or cytotoxic agents at any time during the screening period
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 |
|---|---|---|
| GrafixPLAlso: Tissue AllograftDebridement, GrafixPL application, dressing application, standard compression therapy | Other | GrafixPL |
| ControlDebridement, dressing application, standard compression therapy | Other | Control |
Primary outcome
Complete closure of the index ulcer
Time frame: Up to 84 days after the Baseline Visit
5 secondary outcomes
Time to initial ulcer closure
Time frame: Up to 84 days after the Baseline Visit
Measurement of percent area reduction in ulcers that do not achieve closure
Time frame: 84 days after the Baseline Visit
Proportion of patients with ulcer reoccurrence in Follow-Up Phase
Time frame: Up to 6 months after initial ulcer closure
Proportion of patients in the Crossover Extension Treatment Phase who achieve complete ulcer closure
Time frame: Up to 91 days after initial Treatment Phase
Time to initial ulcer among patients in the Crossover Extension Treatment Phase
Time frame: Up to 91 days after initial Treatment Phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Derived from this study: PubMed 40330756Dhillon Y, Levine L, Tovmassian G, Reyzelman A, Perez-Clavijo F, Wodie F, Cazzell S, Grossman A, Robinson L, Sigal F, Kirsner RS, Vartivarian M, Saunders M, Banerjee J. A Multicenter, Randomized, Controlled, Clinical Trial Evaluating a Lyopreserved Amniotic Membrane in the Treatment of Venous Leg Ulcers. Health Sci Rep. 2025 May 4;8(5):e70819. doi: 10.1002/hsr2.70819. eCollection 2025 May.
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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.
Jaideep Banerjee, PHD study chair
Smith & Nephew, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GrafixPL in people with Venous Leg Ulcer, run by Osiris Therapeutics at 2 sites 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 8 inclusion and 18 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: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete closure of the index ulcer (time frame: Up to 84 days after the Baseline Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03629236, which also lists 1 linked publication.
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 12 Apr 2022.