Varicose UlcerPhase 4AmnioExCelNCT02929056
Amniotic Membrane Allograft Application in the Management of Venous Leg Ulcerations
A Phase 4 study testing AmnioExCel dressing and compression therapy and SOC alginate dressing and compression therapy in people with Varicose Ulcer and Venous Insufficiency, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
The purpose of this study is to evaluate and compare healing characteristics, reduction in the size of the wound and to measure complete healing of the wound following the application of a biologic product dressing instead of the alginate dressing along with standard debridement and compression therapy versus the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Ulcer, Venous Insufficiency
- What is being tested?
- AmnioExCel dressing and compression therapy and SOC alginate dressing and compression therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2017to 29 Oct 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female, 18 years or older
- At least one VLU with a total surface area between 2 cm2 and 100 cm2
- VLU present for at least 1 month
- Presence of a VLU extending through the full thickness of the skin but not down to muscle, tendons, or bones
- Ulcer has a clean, granulating base with minimal adherent slough
- VLU has been treated with compression therapy for at least 14 days
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- The study VLU has < 30% area reduction with SOC treatment for the duration ≥ 2 weeks screening period
- At least one of the following within the last 6 months:
- An Ankle-Brachial Index (ABI) of > 0.75
- Dorsalis Pedis (DP) systolic pressure ≥ 80 mm Hg for diabetic patients or ≥ 60 mm Hg for non-diabetic patients on study limb
- Posterior Tibial (PT) systolic pressure ≥ 80 mm Hg for diabetic patients or ≥ 60 mm Hg for non-diabetic patients on study limb
- Great toe systolic pressure ≥ 40 mm Hg
- Willingness to comply with the protocol, attend all follow-up visits, complete all protocol related assessments and provide informed consent
Who cannot join
- Presence of an active infection of the skin on the target limb such as cellulitis requiring antibiotics
- Ulcer caused by a medical condition other than venous insufficiency
- Ulcer suspicious for cancer
- Known history of AIDS or HIV
- Previously treated with tissue engineered materials (e.g., Apligraft, Dermagraft or EpiFix) or other scaffold materials (e.g., Oasis or Puraply) in the past three months on the target VLU.
- Receipt of a biologic agent, growth factor or skin substitute within the prior 30 days
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- Known sensitivity to ethanol
- Uncontrolled diabetes mellitus with a HgBA1c of > 10% within the past 3 months
- Rheumatoid arthritis
- Significant lower extremity arterial occlusive disease that would preclude the use of compression therapy
- NYHA Class III and IV congestive heart failure (CHF)
- Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus
- Currently receiving radiation therapy or chemotherapy
- Receiving immune modulators
- Currently pregnant or trying to get pregnant
- Breast feeding
- Not willing to provide written informed consent or remain in compliance with the study protocol requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Health System
Greenville, South Carolina, 29615
About this study
Official title: A Prospective Randomized Comparative Parallel Study of Amniotic Membrane in the Management of Venous Leg Ulcerations
The purpose of this study is to evaluate and compare healing characteristics, reduction in the size of the wound and to measure complete healing of the wound following the application of a biologic product dressing instead of the alginate dressing along with standard debridement and compression therapy versus the standard of care treatment for VLUs. The biologic product that will be used in this study is called AmnioExCel™.
Read the detailed description
Approximately 40 participants will be enrolled in this study at the Greenville Health System. Participation is anticipated to last up to 15 weeks and will include a two week screening period, randomization (Visit 1) and office visits at the study doctor's office once every week for up to 12 weeks (Visit 2 - Visit 12). All participants will receive the standard of care wound treatment during the 2 week screening period. The treatment plan outlined in treatment group 1 or treatment group 2 will be followed after randomization.
Participants will be randomly assigned (like flipping a coin) into one of two treatment groups. There is an equal chance to be enrolled into either of the two treatment groups. Neither the participant nor the study doctor can control the group assignment.
Treatment Group 1: participants will receive the standard of care treatment including the use of a multi-layer compression wrap for their VLU.
Treatment Group 2: participants will receive the application of the biologic product AmnioExCel™ dressing instead of the application of an alginate dressing in addition to standard debridement and the use of a multi-layer compression wrap for their VLU. If participants have more than one VLU, only one will be enrolled in the study and will receive the application of the AmnioExCel™ dressing. The remaining VLUs will receive the application of the alginate dressing.
AmnioExCel™ is a human cellular and tissue based product that is registered with the United States Food and Drug Administration (FDA). It is intended for use as a wound covering and is made of a dehydrated human amniotic membrane (innermost layer of the placenta) that was obtained from donated human placenta. The use of AmnioExCel™ specifically for this study is not considered as standard of care.
- Conditions
- Varicose Ulcer, Venous Insufficiency
- Being tested
- AmnioExCel dressing and compression therapy, SOC alginate dressing and compression therapy
- Medical subject headings
- Varicose Ulcer, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmnioExCel dressing and compression therapyBiological
Use of a dehydrated human amnion membrane as a biologic adjunct to the standard of care in patients with venous leg ulcers
SOC alginate dressing and compression therapyProcedure or surgery
Alginate dressing is an absorbent wound care product that contains sodium and calcium fibers to absorb fluids and promote healing
| Study group | Role | What they receive |
|---|---|---|
| SOC alginate dressing | Placebo comparator | SOC absorptive alginate primary dressing in conjunction with a class II multi-layer compression wrap and standard debridement Receives: Procedure: SOC alginate dressing and compression therapy |
| AmnioExCel dressing | Experimental | AmnioExCel dressing in conjunction with a class II multilayer compression wrap and standard debridement Receives: Biological: AmnioExCel dressing and compression therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wound Area
Average percent change in wound area, computed with respect to wound area at time "0". Wound area assessed at baseline (time 0) and then weekly; change from baseline to 12 weeks reported.
Measured: 12 weeks
Secondary outcomes (1)
Change in Patient Pain Score
Pain assessed at weekly visits using the Wong-Baker FACES (Family And Caregiver Education \& Support) Pain Scale. Change from baseline to 12 weeks reported.
Self-report measure of pain from 0 to 10, with higher values representing a worse outcome.
0 = "No hurt" and 10 = "Hurts Worst"
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 posted10 Oct 2016 (estimated)
- Study start15 Feb 2017
- Primary completion6 Sep 2018
- Study completion29 Oct 2019
Why it stopped: grant funding ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Varicose 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- Clemson University, BioDlogics
- Responsible party
- Sponsor
- Investigators
- Thomas Oliver, MD, Principal investigator, Prisma Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929056
- Sponsor's protocol ID
- 00059274
- Acronym
- AmnioExCel
- Status last verified
- Nov 2021
- First submitted
- 7 Oct 2016
- Last updated
- 16 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected from participants who sign consent will be sent in a de-identified fashion to Clemson University for data analysis. Clemson University will submit safety information to BioDLogics, LLC, in a de-identified fashion as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparative Parallel Study of Amniotic Membrane in the Management of Venous Leg Ulcerations
- ClinicalTrials.gov ID
- NCT02929056
- Acronym / sponsor ID
- AmnioExCel / 00059274
- Conditions
- Varicose Ulcer, Venous Insufficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: grant funding ended
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- Clemson University, BioDlogics
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Posted 16 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate and compare healing characteristics, reduction in the size of the wound and to measure complete healing of the wound following the application of a biologic product dressing instead of the alginate dressing along with standard debridement and compression therapy versus the standard of care treatment for VLUs. The biologic product that will be used in this study is called AmnioExCel™.
Detailed description
Approximately 40 participants will be enrolled in this study at the Greenville Health System. Participation is anticipated to last up to 15 weeks and will include a two week screening period, randomization (Visit 1) and office visits at the study doctor's office once every week for up to 12 weeks (Visit 2 - Visit 12). All participants will receive the standard of care wound treatment during the 2 week screening period. The treatment plan outlined in treatment group 1 or treatment group 2 will be followed after randomization.
Participants will be randomly assigned (like flipping a coin) into one of two treatment groups. There is an equal chance to be enrolled into either of the two treatment groups. Neither the participant nor the study doctor can control the group assignment.
Treatment Group 1: participants will receive the standard of care treatment including the use of a multi-layer compression wrap for their VLU.
Treatment Group 2: participants will receive the application of the biologic product AmnioExCel™ dressing instead of the application of an alginate dressing in addition to standard debridement and the use of a multi-layer compression wrap for their VLU. If participants have more than one VLU, only one will be enrolled in the study and will receive the application of the AmnioExCel™ dressing. The remaining VLUs will receive the application of the alginate dressing.
AmnioExCel™ is a human cellular and tissue based product that is registered with the United States Food and Drug Administration (FDA). It is intended for use as a wound covering and is made of a dehydrated human amniotic membrane (innermost layer of the placenta) that was obtained from donated human placenta. The use of AmnioExCel™ specifically for this study is not considered as standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC alginate dressing | Placebo comparator | Procedure: SOC alginate dressing and compression therapySOC absorptive alginate primary dressing in conjunction with a class II multi-layer compression wrap and standard debridement |
| AmnioExCel dressing | Experimental | Biological: AmnioExCel dressing and compression therapyAmnioExCel dressing in conjunction with a class II multilayer compression wrap and standard debridement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female, 18 years or older
- At least one VLU with a total surface area between 2 cm2 and 100 cm2
- VLU present for at least 1 month
- Presence of a VLU extending through the full thickness of the skin but not down to muscle, tendons, or bones
- Ulcer has a clean, granulating base with minimal adherent slough
Key exclusion criteria (17 listed)
- Presence of an active infection of the skin on the target limb such as cellulitis requiring antibiotics
- Ulcer caused by a medical condition other than venous insufficiency
- Ulcer suspicious for cancer
- Known history of AIDS or HIV
- Previously treated with tissue engineered materials (e.g., Apligraft, Dermagraft or EpiFix) or other scaffold materials (e.g., Oasis or Puraply) in the past three months on the target VLU.
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 |
|---|---|---|
| AmnioExCel dressing and compression therapyUse of a dehydrated human amnion membrane as a biologic adjunct to the standard of care in patients with venous leg ulcers | Biological | AmnioExCel dressing |
| SOC alginate dressing and compression therapyAlginate dressing is an absorbent wound care product that contains sodium and calcium fibers to absorb fluids and promote healing | Procedure or surgery | SOC alginate dressing |
Primary outcome
Change in Wound Area
Time frame: 12 weeks
Average percent change in wound area, computed with respect to wound area at time "0". Wound area assessed at baseline (time 0) and then weekly; change from baseline to 12 weeks reported.
1 secondary outcome
Change in Patient Pain Score
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data collected from participants who sign consent will be sent in a de-identified fashion to Clemson University for data analysis. Clemson University will submit safety information to BioDLogics, LLC, in a de-identified fashion as appropriate.
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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.
Thomas Oliver, MD principal investigator
Prisma Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AmnioExCel dressing and compression therapy and SOC alginate dressing and compression therapy in people with Varicose Ulcer and Venous Insufficiency, run by Prisma Health-Upstate 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 13 inclusion and 17 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: stopped early, as of the sponsor's last update on 16 Dec 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Wound Area (time frame: 12 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 16 Dec 2021.