Diabetic Foot UlcerNCT04233580
Characterization of AmnioExcel Plus in Two Treatment Paradigms
A study testing Amnio Excel + weekly and Amnio Excel + max every 2 weeks in people with Diabetic Foot Ulcer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The Investigators plan to evaluate healing in two cohorts of patients with diabetic foot wounds (n=20) that receive optimal treatment including serial wound debridement and off-loading with a boot or postop shoe and AmnioEXCEL+. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Amnio Excel + weekly and Amnio Excel + max every 2 weeks
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2020to 6 Apr 2021
- Phase
- Interventional
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Criteria for Inclusion of Subjects:
- 21-90 years of age
- Able to provide informed consent
- Chronic foot ulceration below the ankle - persistent for >30 days but <6 months
Criteria for Exclusion of Subjects:
- <21 or >90 years of age
- Unable to provide informed consent
- History of poor compliance in the opinion of the investigator
- Gangrene
- Untreated osteomyelitis
- Widespread malignancy
- Active alcohol or substance abuse such as cocaine, heroin, or methamphetamines that in the opinion of the investigator will impact the subject's participation in the study
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
About this study
The Investigators plan to evaluate healing in two cohorts of patients with diabetic foot wounds (n=20) that receive optimal treatment including serial wound debridement and off-loading with a boot or postop shoe and AmnioEXCEL+. In one cohort, AmnioEXCEL+ will be applied weekly at study visits and in the second cohort, AmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC). In addition, the Investigators will collect data on other potential confounding factors that could affect healing such as antibiotic, anti-fungal and anti-infective medications, tobacco, comorbidities, diabetes control, infection, perfusion, and activity. Wound healing, including wound size and adverse events will be evaluated.
Read the detailed description
Study Procedures:
Collection of Demographic data, medical/social history Collection of medications1 Ankle Brachial Index2 Wound debridement3 (standard of care procedure) Imaging with eKare4 Hyperspectral Imaging Application of study product
- Only collect antibiotics, anti-fungal and anti-infective medications.
- ABI (with toe pressure) can be done at screening or baseline.
- Once wound is healed, wound debridement will not be done at weekly visits.
- Once wound is healed, eKare will not be done at weekly visits.
- EOS will occur on the date the subject is healed. *Screening and Visit 1 may be done on the same day.
Screening and Enrollment*:
- Review and sign the Informed Consent and HIPAA Authorization
- Review the inclusion and exclusion criteria
If the subject qualifies for the study, they will participate in the following procedures (weekly visits, +/-4 days):
Visit 1*:
- Demographics (such as age, gender, race or ethnicity)
- Past Medical History, Social History, Medications documented.
- Labs documented as SOC within 6mo of initial visit
- ABI with toe pressures2
- Wound debridement
- eKare wound measurement
- Hyperspectral Imaging
- Randomization
- Application of AmnioEXCEL+
- Source documentation
- Stipend disbursement
Visits 2 through 6:
- Wound debridement3
- eKare wound measurement4
- Hyperspectral imaging
- Application of AmnioEXCEL+ per cohort assignment
- Source documentation
- Stipend disbursement
Visit 7:
- Medications documented
- Wound debridement3
- eKare wound measurement4
- Hyperspectral imaging
- Application of AmnioEXCEL+ per cohort assignment
- Source documentation
- Stipend disbursement
Visits 8-11:
- Wound debridement3
- eKare wound measurement4
- Hyperspectral Imaging
- Application of AmnioEXCEL+ per cohort assignment
- Source documentation
- Stipend disbursement
Visit 12:
- Wound debridement3
- eKare wound measurement4
- Source documentation
- Stipend disbursement
End of Study (EOS) Visit 5:
- Medications documented
- Wound debridement3
- eKare wound measurement4
- Source documentation
- Subject exit from study
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Amnio Excel + weekly, Amnio Excel + max every 2 weeks
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amnio Excel + weeklyDevice
Amnio Excel + weekly
Amnio Excel + max every 2 weeksDevice
Amnio Excel + max every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Weekly AmnioEXCEL+ group | Active comparator | AmnioEXCEL+ will be applied weekly at study visits Receives: Device: Amnio Excel + weekly |
| PRN AmnioEXCEL+ group | Active comparator | AmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC) Receives: Device: Amnio Excel + max every 2 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Healed
Number of participants whose wounds healed during the study timeframe. Reported as dichotomous yes/no.
Measured: 12 weeks
Secondary outcomes (3)
Wound Volume
Wound volume measured by camera which performs a 3D measurement and calculates the volume at baseline
Measured: Baseline
Wound Area
Wound measured by camera which performs a 3D measurement and calculates the area at baseline
Measured: Baseline
Tissue Oxygenation (StO2) of the Dorsal Foot
Tissue oxygenation measured by hyperspectral imaging camera at baseline
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start9 Jul 2020
- Primary completion6 Apr 2021
- Study completion6 Apr 2021
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 Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Responsible party
- Principal investigator, Larry Lavery, University of Texas Southwestern Medical Center
- Investigators
- Lawrence Lavery, DPM MPH, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233580
- Sponsor's protocol ID
- 2019-1527
- Status last verified
- Jul 2023
- First submitted
- 14 Jan 2020
- Last updated
- 24 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of AmnioExcel Plus in Two Treatment Paradigms
- ClinicalTrials.gov ID
- NCT04233580
- Acronym / sponsor ID
- 2019-1527
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 6 Apr 2021 (actual)
- Study completion
- 6 Apr 2021 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Posted 22 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Investigators plan to evaluate healing in two cohorts of patients with diabetic foot wounds (n=20) that receive optimal treatment including serial wound debridement and off-loading with a boot or postop shoe and AmnioEXCEL+. In one cohort, AmnioEXCEL+ will be applied weekly at study visits and in the second cohort, AmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC). In addition, the Investigators will collect data on other potential confounding factors that could affect healing such as antibiotic, anti-fungal and anti-infective medications, tobacco, comorbidities, diabetes control, infection, perfusion, and activity. Wound healing, including wound size and adverse events will be evaluated.
Detailed description
Study Procedures:
Collection of Demographic data, medical/social history Collection of medications1 Ankle Brachial Index2 Wound debridement3 (standard of care procedure) Imaging with eKare4 Hyperspectral Imaging Application of study product
- Only collect antibiotics, anti-fungal and anti-infective medications.
- ABI (with toe pressure) can be done at screening or baseline.
- Once wound is healed, wound debridement will not be done at weekly visits.
- Once wound is healed, eKare will not be done at weekly visits.
- EOS will occur on the date the subject is healed. *Screening and Visit 1 may be done on the same day.
Screening and Enrollment*:
- Review and sign the Informed Consent and HIPAA Authorization
- Review the inclusion and exclusion criteria
If the subject qualifies for the study, they will participate in the following procedures (weekly visits, +/-4 days):
Visit 1*:
- Demographics (such as age, gender, race or ethnicity)
- Past Medical History, Social History, Medications documented.
- Labs documented as SOC within 6mo of initial visit
- ABI with toe pressures2
- Wound debridement
- eKare wound measurement
- Hyperspectral Imaging
- Randomization
- Application of AmnioEXCEL+
- Source documentation
- Stipend disbursement
Visits 2 through 6:
- Wound debridement3
- eKare wound measurement4
- Hyperspectral imaging
- Application of AmnioEXCEL+ per cohort assignment
- Source documentation
- Stipend disbursement
Visit 7:
- Medications documented
- Wound debridement3
- eKare wound measurement4
- Hyperspectral imaging
- Application of AmnioEXCEL+ per cohort assignment
- Source documentation
- Stipend disbursement
Visits 8-11:
- Wound debridement3
- eKare wound measurement4
- Hyperspectral Imaging
- Application of AmnioEXCEL+ per cohort assignment
- Source documentation
- Stipend disbursement
Visit 12:
- Wound debridement3
- eKare wound measurement4
- Source documentation
- Stipend disbursement
End of Study (EOS) Visit 5:
- Medications documented
- Wound debridement3
- eKare wound measurement4
- Source documentation
- Subject exit from study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly AmnioEXCEL+ group | Active comparator | Device: Amnio Excel + weeklyAmnioEXCEL+ will be applied weekly at study visits |
| PRN AmnioEXCEL+ group | Active comparator | Device: Amnio Excel + max every 2 weeksAmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC) |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Amnio Excel + weeklyAmnio Excel + weekly | Device | Weekly AmnioEXCEL+ group |
| Amnio Excel + max every 2 weeksAmnio Excel + max every 2 weeks | Device | PRN AmnioEXCEL+ group |
Primary outcome
Number of Participants Who Healed
Time frame: 12 weeks
Number of participants whose wounds healed during the study timeframe. Reported as dichotomous yes/no.
3 secondary outcomes
Wound Volume
Time frame: Baseline
Wound Area
Time frame: Baseline
Tissue Oxygenation (StO2) of the Dorsal Foot
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
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Better Care Closer to Home: Enhancing Primary and Community Care
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Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
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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.
Lawrence Lavery, DPM MPH principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amnio Excel + weekly and Amnio Excel + max every 2 weeks in people with Diabetic Foot Ulcer, run by University of Texas Southwestern Medical Center 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?
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 24 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 22 Sep 2022). 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?
Number of Participants Who Healed (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 24 Jul 2023.