Diabetic Foot UlcerNCT03010319
PriMatrix for the Management of Diabetic Foot Ulcers
A study testing PriMatrix Dermal Repair Scaffold, Secondary Dressings and Offloading device in people with Diabetic Foot Ulcer, run by Integra LifeSciences Corporation at 17 sites in United States.
Trial summary
The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care treatment. Half of patients will be treated using PriMatrix while the other half will receive Standard of Care treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- PriMatrix Dermal Repair Scaffold, Secondary Dressings and Offloading device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 17 sitesUnited States
- Study dates
- Jan 2017to Aug 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are required to meet all of the following criteria for enrollment into the study and subsequent randomization:
- The subject has signed and dated an informed consent form.
- In the opinion of the investigator, subject is able and willing to comply with study procedures, including study visits, study dressing regimens and compliance with study required off-loading device.
- The subject is ≥ 18 years of age.
- The subject, if female of child-bearing potential, must not be pregnant. To document pregnancy status, subject statement is acceptable.
- The subject has Type I or Type II diabetes mellitus with investigator-confirmed glycosylated hemoglobin (HbA1c) of ≤ 12% within 3 months prior to screening visit.
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- The subject has at least one diabetic foot ulcer that meets ALL of the following criteria:
- Ulcer which has been in existence for a minimum of two weeks, prior to signing the Informed Consent Form for trial participation.
- Ulcer is a partial or full thickness diabetic foot ulcer without capsule/tendon/bone exposure.
- Ulcer does not have tunneling, undermining, or sinus tracts that necessitates surgical OR debridement and/or penetrates to capsule/tendon/bone.
- Ulcer is located on the foot or ankle (with no portion above the top of the malleolus).
- Ulcer size (area) is > 1 cm2 and < 12 cm2 post-debridement.
- There is a minimum 1 cm margin between the qualifying study ulcer and any other ulcer on that same foot, post-debridement.
- If the subject has more than one ulcer that meets the eligibility criteria, the ulcer designated as the study ulcer will be at the discretion of the investigator.
- The subject has adequate vascular perfusion of the affected limb as defined by at least one of the following:
- Ankle-Brachial Index (ABI) ≥ 0.65 or ≤1.2, performed within 3 months of screening,
- Toe pressure (plethysmography) > 50 mmHg at time of screening,
- TcPO2 > 40 mmHg at time of screening
- The subject or responsible caregiver is willing and able to maintain required applicable dressing changes as well as study required off-loading/protective device for the duration of the study.
Who cannot join
- Subjects will not be enrolled in the study if any of the following criteria are met:
- The subject was previously randomized and treated under this clinical study protocol.
- The subject has suspected or confirmed gangrene or ulcer infection of the study ulcer or receiving systemic antibiotics for the treatment of such.
- The subject has suspected or confirmed osteomyelitis of the foot with the study ulcer.
- The subject has a history of hypersensitivity to bovine collagen, as determined by prior medical history.
- Protocol Number: T-PMXDFU-01 Confidential Page 23 of 64 Version 5.0 06 Nov 2018
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- The subject has participated in another clinical trial involving a device or a systemically administered investigational study drug/treatment within 28 days of randomization.
- The subject has received, within 28 of signing Informed Consent Form, or is scheduled to receive during study participation, a medication or treatment which is known to interfere with or affect the rate and quality of ulcer healing (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapy, dialysis, radiation therapy to the foot, vascular surgery, angioplasty, or thrombolysis).
- The subject has a history of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or has had chemotherapy within the 12 months prior to signing Informed Consent Form for trial participation.
- In the opinion of the investigator, the subject has a history of, or is currently diagnosed with, any illness or condition, other than diabetes, that could interfere with ulcer healing (e.g., end-stage renal disease, severe malnutrition, liver disease, aplastic anemia, connective tissue disorder, acquired immune deficiency syndrome, HIV positive, or sickle cell anemia).
- In the opinion of the investigator, the subject has unstable Charcot foot or Charcot with bony prominence that could inhibit ulcer healing.
- The subject has ulcers secondary to a disease other than diabetes (e.g., vasculitis, neoplasms, or hematological disorders).
- In the opinion of the investigator, the subject has excessive lymphedema that could interfere with off-loading and/or ulcer healing.
- The study ulcer has received ulcer dressings that included growth factors, engineered tissues, or skin substitutes within 28 days of randomization or is scheduled to receive treatment during the study (e.g., Regranex, Dermagraft, Apligraf, EpiFix, GraftJacket, OASIS, Omnigraft, or Integra BMWD).
- At the end of the screening phase and based on planimetric assessment, the area of the study ulcer after sharp debridement has decreased by more than 30% over the two-week screening period.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Podiatry 1st
Belleville, Illinois, 62226
ILD Research Center
Carlsbad, California, 92009
Podiatric Medical Partners of Texas, P.A.
Dallas, Texas, 75208
UT Southwestern Medical Center
Dallas, Texas, 75390
JPS Health Network
Fort Worth, Texas, 76104
LA Foot & Ankle Clinic
Los Angeles, California, 90057
Futuro Clinical Trials
McAllen, Texas, 78501
The Mount Sinai Medical Center
New York, New York, 10029
Barry University Clinical Research
North Miami, Florida, 33169
Element Research Group
San Antonio, Texas, 78229
Center for Clinical Research, Inc.
San Francisco, California, 94115
Central Valley Vein and Wound
Selma, California, 93662
Foot and Ankle Institute
St. George, Utah, 84770
Wound Care of Tulsa
Tulsa, Oklahoma, 74146
Georgetown University
Washington D.C., District of Columbia, 20057
LA Podiatry Group
West Palm Beach, Florida, 33406
Martin Foot and Ankle
York, Pennsylvania, 17402
About this study
Official title: Prospective, Multi-center, Randomized, Controlled Trial Evaluating the Use of PriMatrix Dermal Repair Scaffold for the Management of Diabetic Foot Ulcers
The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care treatment. Half of patients will be treated using PriMatrix while the other half will receive Standard of Care treatment.
Read the detailed description
A diabetic foot ulcer (DFU) is a major health complication that affects up to 15% of individuals with diabetes mellitus over their lifetime. The treatment of DFUs is extremely challenging as these ulcers may not respond to standard of care (SC) treatment and frequently become infected.
Advanced wound therapies like PriMatrix have become an important strategy in the treatment of hard-to-heal chronic DFUs by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing.
The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the closure of DFUs in subjects with diabetes mellitus in comparison to Standard of Care treatment.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- PriMatrix Dermal Repair Scaffold, Secondary Dressings, Offloading device
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PriMatrix Dermal Repair ScaffoldDevice
Application of PriMatrix to ulcer
Secondary DressingsDevice
Dressings to ensure moist wound environment
Offloading deviceDevice
Offloading device to decrease pressure to wound area
| Study group | Role | What they receive |
|---|---|---|
| PriMatrix | Experimental | Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device. Receives: Device: PriMatrix Dermal Repair Scaffold; Device: Secondary Dressings; Device: Offloading device |
| Standard of Care | Active comparator | Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device. Receives: Device: Secondary Dressings; Device: Offloading device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Complete Wound Closure, as Assessed by the Investigator, at or Before Week 12 of the Treatment Phase
Complete wound closure was defined as 100% re-epithelialization of the ulcer surface without detectable exudate, confirmed on 2 consecutive study visits 1 week apart.
Measured: 12-week Treatment Phase
Secondary outcomes (4)
Percentage of Subjects With Complete Wound Closure, as Assessed by Computerized Planimetry, at or Before Week 12 of the Treatment Phase
Measured: 12-week treatment phase
Time to Complete Wound Closure, as Assessed by the Investigator
Measured: 12-week Treatment Phase
Time to Complete Wound Closure, as Assessed by Computerized Planimetry.
Measured: 12-week Treatment Phase
Rate of Wound Closure, as Assessed by Computerized Planimetry.
Rate of Wound closure was recorded as the percentage of the wound that was closed, per week.
NOTE1: Rate (% closed/week) = 7 * [(Baseline wound size) - (Post-baseline wound size)]/[(Baseline wound size) * (days in trial)] NOTE2: Missing data is imputed using LOCF method for this analysis
Measured: Weeks 1-12 during Treatment Phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionAug 2020
- Study completionAug 2020
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.
- 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
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Lantis, MD, Principal investigator, The Mount Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010319
- Sponsor's protocol ID
- T-PMXDFU-001
- Status last verified
- Apr 2022
- First submitted
- 3 Jan 2017
- Last updated
- 29 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Individual Patient Data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Randomized, Controlled Trial Evaluating the Use of PriMatrix Dermal Repair Scaffold for the Management of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT03010319
- Acronym / sponsor ID
- T-PMXDFU-001
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Posted 15 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care treatment. Half of patients will be treated using PriMatrix while the other half will receive Standard of Care treatment.
Detailed description
A diabetic foot ulcer (DFU) is a major health complication that affects up to 15% of individuals with diabetes mellitus over their lifetime. The treatment of DFUs is extremely challenging as these ulcers may not respond to standard of care (SC) treatment and frequently become infected.
Advanced wound therapies like PriMatrix have become an important strategy in the treatment of hard-to-heal chronic DFUs by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing.
The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the closure of DFUs in subjects with diabetes mellitus in comparison to Standard of Care treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PriMatrix | Experimental | Device: PriMatrix Dermal Repair Scaffold, Device: Secondary Dressings, Device: Offloading deviceArm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device. |
| Standard of Care | Active comparator | Device: Secondary Dressings, Device: Offloading deviceArm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subjects are required to meet all of the following criteria for enrollment into the study and subsequent randomization:
- The subject has signed and dated an informed consent form.
- In the opinion of the investigator, subject is able and willing to comply with study procedures, including study visits, study dressing regimens and compliance with study required off-loading device.
- The subject is ≥ 18 years of age.
- The subject, if female of child-bearing potential, must not be pregnant. To document pregnancy status, subject statement is acceptable.
Key exclusion criteria (15 listed)
- The subject was previously randomized and treated under this clinical study protocol.
- The subject has suspected or confirmed gangrene or ulcer infection of the study ulcer or receiving systemic antibiotics for the treatment of such.
- The subject has suspected or confirmed osteomyelitis of the foot with the study ulcer.
- The subject has a history of hypersensitivity to bovine collagen, as determined by prior medical history.
- Protocol Number: T-PMXDFU-01 Confidential Page 23 of 64 Version 5.0 06 Nov 2018
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 |
|---|---|---|
| PriMatrix Dermal Repair ScaffoldApplication of PriMatrix to ulcer | Device | PriMatrix |
| Secondary DressingsDressings to ensure moist wound environment | Device | PriMatrix, Standard of Care |
| Offloading deviceOffloading device to decrease pressure to wound area | Device | PriMatrix, Standard of Care |
Primary outcome
Percentage of Subjects With Complete Wound Closure, as Assessed by the Investigator, at or Before Week 12 of the Treatment Phase
Time frame: 12-week Treatment Phase
Complete wound closure was defined as 100% re-epithelialization of the ulcer surface without detectable exudate, confirmed on 2 consecutive study visits 1 week apart.
4 secondary outcomes
Percentage of Subjects With Complete Wound Closure, as Assessed by Computerized Planimetry, at or Before Week 12 of the Treatment Phase
Time frame: 12-week treatment phase
Time to Complete Wound Closure, as Assessed by the Investigator
Time frame: 12-week Treatment Phase
Time to Complete Wound Closure, as Assessed by Computerized Planimetry.
Time frame: 12-week Treatment Phase
Rate of Wound Closure, as Assessed by Computerized Planimetry.
Time frame: Weeks 1-12 during Treatment Phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual Patient Data will not be shared.
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
Recruiting
DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
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.
John Lantis, MD principal investigator
The Mount Sinai Medical Center
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PriMatrix Dermal Repair Scaffold, Secondary Dressings and Offloading device in people with Diabetic Foot Ulcer, run by Integra LifeSciences Corporation at 17 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 19 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: finished, as of the sponsor's last update on 29 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 17 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?
Yes. Results are posted in the registry (first posted 15 Mar 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?
Percentage of Subjects With Complete Wound Closure, as Assessed by the Investigator, at or Before Week 12 of the Treatment Phase (time frame: 12-week Treatment Phase). 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 29 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.