Neuropathic Diabetic Foot UlcerM-S-DFU-RCTNCT02750280
A Longitudinal Study to Evaluate an Extracellular Matrix (MatriStem®) for the Treatment of Diabetic Foot Ulcers
A study testing MatriStem® [Urinary Bladder Matrix (UBM)] and Mepilex® [Silicone foam dressing] in people with Neuropathic Diabetic Foot Ulcer, run by Calvary Hospital, Bronx, NY at 1 site in United States.
Trial summary
This ia a prospective controlled longitudinal study to evaluate the effects of MatriStem® plus standard local wound care versus standard local wound care alone in the treatment of diabetic foot ulcers (DFUs), as assessed by incidence of complete wound healing by 16 weeks and ulcer recurrence with a 2 year follow-up. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neuropathic Diabetic Foot Ulcer
- What is being tested?
- MatriStem® [Urinary Bladder Matrix (UBM)] and Mepilex® [Silicone foam dressing]
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Dec 2015
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects 18-85 years of age with diabetes mellitus (type 1 or type 2)
- Subject's foot ulcer is on the plantar surface of the foot.
- DFU has not healed after more than2 months of SOC treatment administered
- Subject's ulcer must be Wagner type 1 or 2 (uninfected, extending through the dermis and into subcutaneous tissue or granulating but without exposure of tendon, bone, or joint capsule.
- Subject's wound is free of necrotic debris (post debridement) and clinical infection, should be comprised of healthy, vascular tissue.
- Subject's Ankle-Brachial Index (ABI) by Doppler method is ≥ 0.7
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- The subject has adequate circulation to the foot to allow for healing. This must be demonstrated by methods described in section 5.1
- Subject's diabetes is under control as determined by the Investigator
- Study subject must be reliable, responsible and able to visit the clinic weekly for the full 16 week period. The subject is willing and able to tolerate TCC. Subject is willing to comply with the monthly follow-up regimen for 32 weeks (8 months) The subject is able to return to the clinic if ulcer recurrence occurs
- Subject or his/her legal representative has read and signed the Institutional Review Board (IRB) approved Informed Consent form before treatment
- No active malignancy except non-melanoma skin cancer
Who cannot join
- Subject has clinical evidence of gangrene on any part of the affected foot
- Subject has a Wagner type 3 or greater ulceration
- The subject's ulcer is due to a non-diabetic etiology, Ulcers of arterial, venous stasis, pressure, radiation, traumatic, rheumatoid, vasculitis, collagen vascular disease, or other non-diabetic etiologies
- Subject has a known sensitivity to bovine or porcine derived devices
- Subject has one or more medical condition(s) including renal, hepatic, hematological, neurologic, or immune disease that in the opinion of the Investigator would make the subject an inappropriate candidate for this wound healing study
- Subject has or has had a malignant disease (other than cutaneous epithelioma) not in remission
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- Subject is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, or is anticipated to require such agents during the course of the study
- Subject has chronic osteomyelitis as determined by high resolution ultrasonography
- Subject's ulcer is infected or accompanied by active cellulitis as determined by the Investigator
- Subject has any condition(s) that seriously compromises the subject's ability to complete the study
- Subject is pregnant or lactating at the time of treatment
- Subject has received growth factor therapy (e.g. autologous platelet-rich plasma gel, bacaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of enrollment. If Santyl or any other collagenase is used, a subject must have a washout period of 2 weeks before MatriStem® can be applied.
- Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization
- Subject has a history of alcohol or drug abuse
- Subject allergic to a broad spectrum of primary \& secondary dressing materials, including occlusive dressings and the adhesives on such dressings.
- Subject is currently enrolled or participated within the previous 30 days of enrollment in another device, drug or biological trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Calvary Hospital Center for Curative and Palliative Wound Care
The Bronx, New York, 10461
About this study
Official title: A Prospective, Randomized, Controlled, Longitudinal Study Using Repeated Measures Design to Evaluate a Porcine Urinary Bladder-Derived Extracellular Matrix (MatriStem®) in the Management of Diabetic Foot Ulcers
This ia a prospective controlled longitudinal study to evaluate the effects of MatriStem® plus standard local wound care versus standard local wound care alone in the treatment of diabetic foot ulcers (DFUs), as assessed by incidence of complete wound healing by 16 weeks and ulcer recurrence with a 2 year follow-up.
- Conditions
- Neuropathic Diabetic Foot Ulcer
- Being tested
- MatriStem® [Urinary Bladder Matrix (UBM)], Mepilex® [Silicone foam dressing]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MatriStem® [Urinary Bladder Matrix (UBM)]Device
Also called MatriStem
Porcine derived urinary bladder extracellular matrix
Mepilex® [Silicone foam dressing]Device
Also called Mepilex
primary wound dressing
| Study group | Role | What they receive |
|---|---|---|
| Urinary Bladder matrix (UBM) | Experimental | UBM covered with silicone foam dressing plus total contact cast Receives: Device: MatriStem® [Urinary Bladder Matrix (UBM)] |
| Standard Care | Active comparator | Silicone foam dressing plus total contact cast Receives: Device: Mepilex® [Silicone foam dressing] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of wound healing
Measured: 16 weeks
Secondary outcomes (1)
Incidence of ulcer recurrence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calvary Hospital, Bronx, NY
- Sponsor type
- University, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Responsible party
- Principal investigator, Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY
- Investigators
- oscar Alvarez, PhD, Principal investigator, Calvary Hospital Director, Center for curative and palliative wound care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750280
- Sponsor's protocol ID
- CA2014-002
- Acronym
- M-S-DFU-RCT
- Status last verified
- Apr 2016
- First submitted
- 21 Apr 2016
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Longitudinal Study Using Repeated Measures Design to Evaluate a Porcine Urinary Bladder-Derived Extracellular Matrix (MatriStem®) in the Management of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT02750280
- Acronym / sponsor ID
- M-S-DFU-RCT / CA2014-002
- Conditions
- Neuropathic Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Calvary Hospital, Bronx, NYUniversity, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Apr 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 ia a prospective controlled longitudinal study to evaluate the effects of MatriStem® plus standard local wound care versus standard local wound care alone in the treatment of diabetic foot ulcers (DFUs), as assessed by incidence of complete wound healing by 16 weeks and ulcer recurrence with a 2 year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urinary Bladder matrix (UBM) | Experimental | Device: MatriStem® [Urinary Bladder Matrix (UBM)]UBM covered with silicone foam dressing plus total contact cast |
| Standard Care | Active comparator | Device: Mepilex® [Silicone foam dressing]Silicone foam dressing plus total contact cast |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male and female subjects 18-85 years of age with diabetes mellitus (type 1 or type 2)
- Subject's foot ulcer is on the plantar surface of the foot.
- DFU has not healed after more than2 months of SOC treatment administered
- Subject's ulcer must be Wagner type 1 or 2 (uninfected, extending through the dermis and into subcutaneous tissue or granulating but without exposure of tendon, bone, or joint capsule.
- Subject's wound is free of necrotic debris (post debridement) and clinical infection, should be comprised of healthy, vascular tissue.
Key exclusion criteria (16 listed)
- Subject has clinical evidence of gangrene on any part of the affected foot
- Subject has a Wagner type 3 or greater ulceration
- The subject's ulcer is due to a non-diabetic etiology, Ulcers of arterial, venous stasis, pressure, radiation, traumatic, rheumatoid, vasculitis, collagen vascular disease, or other non-diabetic etiologies
- Subject has a known sensitivity to bovine or porcine derived devices
- Subject has one or more medical condition(s) including renal, hepatic, hematological, neurologic, or immune disease that in the opinion of the Investigator would make the subject an inappropriate candidate for this wound healing study
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 |
|---|---|---|
| MatriStem® [Urinary Bladder Matrix (UBM)]Also: MatriStemPorcine derived urinary bladder extracellular matrix | Device | Urinary Bladder matrix (UBM) |
| Mepilex® [Silicone foam dressing]Also: Mepilexprimary wound dressing | Device | Standard Care |
Primary outcome
Incidence of wound healing
Time frame: 16 weeks
1 secondary outcome
Incidence of ulcer recurrence
Time frame: 1 year
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 25 Apr 2016.
- Individual participant dataSharing planned: No
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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.
oscar Alvarez, PhD principal investigator
Calvary Hospital Director, Center for curative and palliative wound care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MatriStem® [Urinary Bladder Matrix (UBM)] and Mepilex® [Silicone foam dressing] in people with Neuropathic Diabetic Foot Ulcer, run by Calvary Hospital, Bronx, NY 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 11 inclusion and 16 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 25 Apr 2016. 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?
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?
Incidence of wound healing (time frame: 16 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 25 Apr 2016.