Diabetic Foot UlcersPhase 4NCT02081352
A Comparative Efficacy Study of DermaPure™ to Treat Diabetic Foot Ulcers
A Phase 4 study testing DermaPure™ in people with Diabetic Foot Ulcers, run by TRx Wound Care Limited at 7 sites in United States.
Trial summary
This study has been designed to help determine how safe and effective DermaPure™ may be in treating hard-to-heal diabetic foot ulcers compared to the current standard of care. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- DermaPure™
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2014to Feb 2017
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 or Type 2 diabetes with HbA1c ≤12%
- Adequate perfusion
- A full thickness chronic, neuropathic diabetic foot plantar ulcer defined by Texas or Wagner classification.
- Target ulcer decreases in size (surface area) by less than 30% in the 2 week screening period.
Who cannot join
- BMI greater than 45kg/m2.
- Presence of infection
- Presence of necrosis, purulence or sinus tracts that cannot be removed by aggressive debridement.
- A clinical diagnosis of an active/acute Charcot neuroarthropathy. Inactive/chronic Charcot does not exclude the patient.
- Therapy with any investigational agent or drug within 4 weeks preceding the screening visit.
- More than 2 weeks treatment with immunosuppressive agents within 3 months of enrollment.
- Evidence of malnutrition as confirmed by serum pre-albumin level at screening.
- Evidence of drug or alcohol abuse,
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
Howard Kashefsky, 919-966-2898
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390-8560
Javier LaFontaine, DPM, 214-648-2132
- Recruiting
Futuro Clinical Trials, LLC
McAllen, Texas, 78501
Joseph Caporusso, DPM, 956-971-9107
- Recruiting
University of Miami Hospital
Miami, Florida, 33136
Robert Kirsner, 305-243-6191
- Recruiting
NYU Langone Medical Center
New York, New York, 10016
Ernest Chiu, MD, 212-263-4355
- Recruiting
Carl T. Hayden Medical Research Foundation
Phoenix, Arizona, 85012-1892
Robert Frykberg, 602-277-5551
- Recruiting
Associated Foot & Ankle Specialists
Phoenix, Arizona, 85015
Arthur Tallis, DPM, 602-274-4100
About this study
Official title: Phase IV Prospective, Multi-Center, Randomized, Single-Blind, Active and Standard Care-Controlled Study of DermaPure™ in Patients With "Hard to Heal" Chronic, Neuropathic Diabetic Foot Ulcers With Crossover Design for Standard Care Arm
This study has been designed to help determine how safe and effective DermaPure™ may be in treating hard-to-heal diabetic foot ulcers compared to the current standard of care.
Read the detailed description
DermaPure™ is a decellularized dermal skin substitute using the Tissue Regenix dCELL® patented Technology to remove cells and other components from human and animal tissue while maintaining the native structural and biomechanical properties. The primary objective of the study is to establish the wound healing performance and safety of DermaPure™ over a 12 week period, when administered to "hard to heal" chronic, neuropathic diabetic foot ulcers. This study has been designed to compare the performance of DermaPure™ (in combination with standard care) versus standard care alone.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- DermaPure™, Standard care
- Keywords
- Dermis, Diabetic foot ulcers, Skin substitutes, Decellularized
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermaPure™Other
A minimally manipulated human tissue regulated as "human cells, tissues, and cellular and tissue-based products" (HCT/Ps)
Standard careOther
| Study group | Role | What they receive |
|---|---|---|
| DermaPure™ | Active comparator | DermaPure™ in combination with standard care comprising surgical debridement, covered by a non-adherent silicone wound contact layer, a wound cavity filler (if required), a secondary foam wound dressing and appropriate off-loading footwear. Receives: Other: DermaPure™ |
| Standard care | Sham comparator | Standard care comprising surgical debridement, covered by a non-adherent silicone wound contact layer, a wound cavity filler (if required), a secondary foam wound dressing and appropriate off-loading footwear. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of wound closure
The incidence of full wound closure at or before 12 weeks, where full wound closure is defined as "100% re-epithelialization, without drainage, that has been confirmed at two study visits up to 14 days apart".
Measured: 12 weeks
Secondary outcomes (2)
Rate of wound healing
Percentage reduction in ulcer area and volume, weekly up to Week 12 compared to baseline.
Measured: 12 weeks
Quality of wound healing
Cellular profile through histological analysis of wound biopsies at Week 4 compared to baseline
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TRx Wound Care Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081352
- Sponsor's protocol ID
- TRG-H01-01
- Status last verified
- Nov 2015
- First submitted
- 5 Mar 2014
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Prospective, Multi-Center, Randomized, Single-Blind, Active and Standard Care-Controlled Study of DermaPure™ in Patients With "Hard to Heal" Chronic, Neuropathic Diabetic Foot Ulcers With Crossover Design for Standard Care Arm
- ClinicalTrials.gov ID
- NCT02081352
- Acronym / sponsor ID
- TRG-H01-01
- Conditions
- Diabetic Foot Ulcers
- Keywords
- Dermis, Diabetic foot ulcers, Skin substitutes, Decellularized
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- TRx Wound Care LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 7 Mar 2014 (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 has been designed to help determine how safe and effective DermaPure™ may be in treating hard-to-heal diabetic foot ulcers compared to the current standard of care.
Detailed description
DermaPure™ is a decellularized dermal skin substitute using the Tissue Regenix dCELL® patented Technology to remove cells and other components from human and animal tissue while maintaining the native structural and biomechanical properties. The primary objective of the study is to establish the wound healing performance and safety of DermaPure™ over a 12 week period, when administered to "hard to heal" chronic, neuropathic diabetic foot ulcers. This study has been designed to compare the performance of DermaPure™ (in combination with standard care) versus standard care alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DermaPure™ | Active comparator | Other: DermaPure™DermaPure™ in combination with standard care comprising surgical debridement, covered by a non-adherent silicone wound contact layer, a wound cavity filler (if required), a secondary foam wound dressing and appropriate off-loading footwear. |
| Standard care | Sham comparator | Other: Standard careStandard care comprising surgical debridement, covered by a non-adherent silicone wound contact layer, a wound cavity filler (if required), a secondary foam wound dressing and appropriate off-loading footwear. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 or Type 2 diabetes with HbA1c ≤12%
- Adequate perfusion
- A full thickness chronic, neuropathic diabetic foot plantar ulcer defined by Texas or Wagner classification.
- Target ulcer decreases in size (surface area) by less than 30% in the 2 week screening period.
Key exclusion criteria (8 listed)
- BMI greater than 45kg/m2.
- Presence of infection
- Presence of necrosis, purulence or sinus tracts that cannot be removed by aggressive debridement.
- A clinical diagnosis of an active/acute Charcot neuroarthropathy. Inactive/chronic Charcot does not exclude the patient.
- Therapy with any investigational agent or drug within 4 weeks preceding the screening visit.
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 |
|---|---|---|
| DermaPure™A minimally manipulated human tissue regulated as "human cells, tissues, and cellular and tissue-based products" (HCT/Ps) | Other | DermaPure™ |
| Standard care | Other | Standard care |
Primary outcome
Incidence of wound closure
Time frame: 12 weeks
The incidence of full wound closure at or before 12 weeks, where full wound closure is defined as "100% re-epithelialization, without drainage, that has been confirmed at two study visits up to 14 days apart".
2 secondary outcomes
Rate of wound healing
Time frame: 12 weeks
Quality of wound healing
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
Related trials for Diabetic Foot Ulcers
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
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DermaPure™ in people with Diabetic Foot Ulcers, run by TRx Wound Care Limited 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 4 inclusion and 8 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 5 Nov 2015. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sheila nicholson (+44 3304303066, s.nicholson@tissueregenix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of wound closure (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 5 Nov 2015.