Venous UlcerTMArtacentNCT02838784
Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers
A study testing Artacent Human Amniotic Membrane in people with Venous Ulcer and Foot Ulcer, Diabetic, run by Tides Medical at 7 sites in United States.
Trial summary
This study will compare the proportion of patients who have wound closure within 12 weeks as well as the time to wound closure in patients receiving Artacent™ versus standard of care for treatment of non-healing lower extremity wounds. The recurrence of healed wounds will be assessed at 6 months via a telephone survey Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Ulcer, Foot Ulcer, Diabetic
- What is being tested?
- Artacent Human Amniotic Membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2016to Dec 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Able and willing to give consent and to comply with study
- Lower extremity ulcer between 1 and 25 cm2 point after the 4 week run-in period
- Has received documented SOC treatment for 4 weeks or greater duration resulting in <50% reduction in the ulcer size
- No clinical signs of infection at the ulcer site
- Serum Creatinine below 3.0 mg/dl
- Serum HgA1c below 12%
- Adequate circulation to the affected limb with ABI between 0.7 and 1.2 or tri-/bi-phasic arterial waveforms at the ankle of the affected leg.
Who cannot join
- Is participating in another wound study
- Has a Charcot foot
- Has previously received a different biological graft on the target foot
- Has more than one lower extremity ulcer
- Has an ulcer that probes to bone or involves tendon, muscle, joint capsule or has sinus tracts
- Is currently receiving radiation or chemotherapy
Show all 9Show fewer
- Has an autoimmune connective tissue disorder
- Is taking any medication known to be an immune system modulator
- Is pregnant or is considering becoming pregnant within the next 6 months
Trial locations and contacts
7 sites in 1 country.
Abigail Allen contact
7 sites in 1 country
United States7 sites, 6 recruiting
- Recruiting
Global Podiatry Partners, Inc
Arcadia, California, 91007
Wenjay Sung, DPM, 626-275-2195
Amy Keyzer, 626-275-2195
- Recruiting
Southwest Austin Foot & Ankle Clinic, PLLC
Austin, Texas, 78735
Mark Whitesides, DPM, 512-447-4122
Cindy Whitesides, 512-447-4122
- Recruiting
Livingston Podiatry Associates PLLC
Bellmore, New York, 11710
Michael Livingston, DPM, 516-308-4500
Donna Knepple, 516-308-4500
- Recruiting
Foot & Ankle Physicians of Ohio
Grove City, Ohio, 43123
Elizabeth Hewitt, DPM, 614-782-3668
Tracy Perez, 614-782-3668
- Recruiting
Iberia Medical Center
New Iberia, Louisiana, 70560
Michelle Menard, DPM, 337-367-0271
Brandi Angelle, 337-367-0271
- Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Noah Oliver, DPM, 504-842-8751
Terri Lopez, 504-842-8751
- Completed
Foot & Ankle Center of Nebraska
Omaha, Nebraska, 68114
About this study
Official title: The Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers: A Prospective Randomized Study
This study will compare the proportion of patients who have wound closure within 12 weeks as well as the time to wound closure in patients receiving Artacent™ versus standard of care for treatment of non-healing lower extremity wounds. The recurrence of healed wounds will be assessed at 6 months via a telephone survey
Read the detailed description
This study is to document the efficacy of Artacent™ Human Amniotic Membrane (Artacent) in the treatment of diabetic and vascular lower extremity ulcers. The study will add to the currently available literature by also assessing the impact of treatment on quality of life and on heal economic outcomes. Finally the study will follow patients for longer than previous studies and will obtain data on healing and recurrence at 6 months.
The objectives of this study are 1) to compare Artacent to standard of care (SOC) in the treatment of non-healing lower extremity ulcers and 2) to evaluate the impact of treatment on patient quality of life. Health economic outcomes will also be collected. The proportion of patients receiving Artacent who have wound closure with 12 weeks will be compared to those patients receiving SOC only will be compared. A comparison of time to wound closure will also be compared between the two populations.
Patients who are randomized to the SOC group (control) and require further treatment at 12 weeks due to incomplete wound healing, may receive treatment with Artacent if the investigator determines that to be a potentially beneficial option.
- Conditions
- Venous Ulcer, Foot Ulcer, Diabetic
- Being tested
- Artacent Human Amniotic Membrane, Standard of Care
- Medical subject headings
- Varicose Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artacent Human Amniotic MembraneOther
Also called Amniotic tissue allograft, Amniotic placental membranes
Double layer dehydrated amnion product
Standard of CareProcedure or surgery
Also called Debridement, Off-loading, non-adherent dressings
Off loading with a cast walker, non-adherent dressings, debridement and moisture retentive dressings
| Study group | Role | What they receive |
|---|---|---|
| Artacent Human Amniotic Membrane | Experimental | Patients randomized to the Artacent group will receive standard of care (off-loading with a removable cast walker and non-adherent dressings in addition to debridement and use of moisture retentive dressing) and the application of the Artacent amniotic allograft once every two weeks for up to 5 applications or until the ulcer has healed. Receives: Other: Artacent Human Amniotic Membrane |
| Lower Extremity Ulcer Standard of Care | Active comparator | Patients randomized to standard of care will receive off-loading with a removable cast walker and non-adherent dressings (e.g. Adaptic) in addition to debridement and use of moisture retentive dressings. An outer dressing will also be applied. Receives: Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound closure
100% re-epithelialization of the wound without drainage or need for use of a dressing
Measured: 12 weeks
Time to wound closure
# of days to 50% or greater closure
Measured: 12 weeks
Ulcer recurrence
Telephone survey to capture number of ulcer recurrences and treatment
Measured: 6 months
Secondary outcomes (5)
Quality of Life
EQ-5D survey
Measured: 12 weeks
Impact of Treatment on Return to Work
Employment status e.g. full-time, part-time, retired, unemployed, etc.
Measured: 12 weeks
Time to full weight bearing status
Ability of the subject to bear full weight and the time to full weight bearing
Measured: 12 weeks
Adverse Events and Secondary Treatments
Measured: 12 weeks
Number of grafts and graft size(s)
Number and size of grafts used at each application will be collected.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tides Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838784
- Sponsor's protocol ID
- 16-001
- Acronym
- TMArtacent
- Status last verified
- Oct 2017
- First submitted
- 15 Jul 2016
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02838784
- Acronym / sponsor ID
- TMArtacent / 16-001
- Conditions
- Venous Ulcer, Foot Ulcer, Diabetic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Tides MedicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 Jul 2016 (estimated)
- 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 study will compare the proportion of patients who have wound closure within 12 weeks as well as the time to wound closure in patients receiving Artacent™ versus standard of care for treatment of non-healing lower extremity wounds. The recurrence of healed wounds will be assessed at 6 months via a telephone survey
Detailed description
This study is to document the efficacy of Artacent™ Human Amniotic Membrane (Artacent) in the treatment of diabetic and vascular lower extremity ulcers. The study will add to the currently available literature by also assessing the impact of treatment on quality of life and on heal economic outcomes. Finally the study will follow patients for longer than previous studies and will obtain data on healing and recurrence at 6 months.
The objectives of this study are 1) to compare Artacent to standard of care (SOC) in the treatment of non-healing lower extremity ulcers and 2) to evaluate the impact of treatment on patient quality of life. Health economic outcomes will also be collected. The proportion of patients receiving Artacent who have wound closure with 12 weeks will be compared to those patients receiving SOC only will be compared. A comparison of time to wound closure will also be compared between the two populations.
Patients who are randomized to the SOC group (control) and require further treatment at 12 weeks due to incomplete wound healing, may receive treatment with Artacent if the investigator determines that to be a potentially beneficial option.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artacent Human Amniotic Membrane | Experimental | Other: Artacent Human Amniotic MembranePatients randomized to the Artacent group will receive standard of care (off-loading with a removable cast walker and non-adherent dressings in addition to debridement and use of moisture retentive dressing) and the application of the Artacent amniotic allograft once every two weeks for up to 5 applications or until the ulcer has healed. |
| Lower Extremity Ulcer Standard of Care | Active comparator | Procedure: Standard of CarePatients randomized to standard of care will receive off-loading with a removable cast walker and non-adherent dressings (e.g. Adaptic) in addition to debridement and use of moisture retentive dressings. An outer dressing will also be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older
- Able and willing to give consent and to comply with study
- Lower extremity ulcer between 1 and 25 cm2 point after the 4 week run-in period
- Has received documented SOC treatment for 4 weeks or greater duration resulting in <50% reduction in the ulcer size
- No clinical signs of infection at the ulcer site
Key exclusion criteria (9 listed)
- Is participating in another wound study
- Has a Charcot foot
- Has previously received a different biological graft on the target foot
- Has more than one lower extremity ulcer
- Has an ulcer that probes to bone or involves tendon, muscle, joint capsule or has sinus tracts
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 |
|---|---|---|
| Artacent Human Amniotic MembraneAlso: Amniotic tissue allograft, Amniotic placental membranesDouble layer dehydrated amnion product | Other | Artacent Human Amniotic Membrane |
| Standard of CareAlso: Debridement, Off-loading, non-adherent dressingsOff loading with a cast walker, non-adherent dressings, debridement and moisture retentive dressings | Procedure or surgery | Lower Extremity Ulcer Standard of Care |
Primary outcome
Wound closure
Time frame: 12 weeks
100% re-epithelialization of the wound without drainage or need for use of a dressing
Time to wound closure
Time frame: 12 weeks
# of days to 50% or greater closure
Ulcer recurrence
Time frame: 6 months
Telephone survey to capture number of ulcer recurrences and treatment
5 secondary outcomes
Quality of Life
Time frame: 12 weeks
Impact of Treatment on Return to Work
Time frame: 12 weeks
Time to full weight bearing status
Time frame: 12 weeks
Adverse Events and Secondary Treatments
Time frame: 12 weeks
Number of grafts and graft size(s)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
Abigail Allen contact
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artacent Human Amniotic Membrane in people with Venous Ulcer and Foot Ulcer, Diabetic, run by Tides Medical at 7 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 9 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 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abigail Allen (aallen@mcra.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound closure (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 13 Oct 2017.