Diabetic Foot UlcerNCT01970163
DermACELL in Subjects With Chronic Wounds of the Lower Extremities
A study testing DermACELL, GraftJacket and Conventional Care Dressings in people with Diabetic Foot Ulcer, run by LifeNet Health at 12 sites in United States.
Trial summary
The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU). Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- DermACELL, GraftJacket and Conventional Care Dressings
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 12 sitesUnited States
- Study dates
- Oct 2013to Apr 2016
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female between the ages of 21 and 80 that are able to provide informed consent, are available for weekly clinic visits and are willing to comply with off-loading requirements of treatment;
- If diabetic, have been on a stable dose of medication to treat diabetes for less than 30 days;
- Have a DFU that has been present for at least 30 days or have a VSU that has been present for at least 60 days;
Who cannot join
- Have a DFU or VSU that is infected;
- Are pregnant or lactating;
- Have an allergy or are sensitive to one of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin;
- Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol;
- Have had a HbA1c level greater than 12% within the past 90 days;
- Have liver function tests or kidney function tests that are very elevated;
Show all 11Show fewer
- Have a known or suspected disease of the immune system;
- Have had surgery in the past 30 days to increase blood flow into your leg or foot;
- Have cancer or a connective tissue disease (i.e. lupus, rheumatoid arthritis);
- Have undergone wound healing treatment with a living skin equivalent (i.e., Dermagraft®, Apligraf®, TheraSkin®, Oasis®, GraftJacket®, Integra®, Alloderm®) or topical growth factors in the last 4 weeks;
- Have active Charcot disease, a weakening of the bones in the foot that can occur in people who have significant nerve damage (neuropathy);
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Boston Medical College
Boston, Massachusetts, 02118
ILD Research Center
Carlsbad, California, 92009
Center for Clinical Research
Castro Valley, California, 94546
Wound Institute and Reseach Center
Dunmore, Pennsylvania, 18512
Limb Preservation Platform
Fresno, California, 93720
Limb Preservation Platform
Fresno, California, 93721
Andrews Research and Education Institute
Gulf Breeze, Florida, 32561
Institute for Advanced Wound Care
Montgomery, Alabama, 36111
Rosalind Franklin University, CLEAR
North Chicago, Illinois, 60064
Fairfield County Foot Surgeons
Norwalk, Connecticut, 06851
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
About this study
Official title: A Multicenter, Randomized, Controlled, Open Label Trial of DermACELL in Subjects With Chronic Wounds of the Lower Extremities
The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).
Read the detailed description
This study is designed to demonstrate the effectiveness of DermACELL in the treatment of chronic wounds of the lower extremities. DermACELL will be compared to conventional care in both subjects with diabetic foot ulcers (DFU) and subjects with venous stasis ulcers (VSU). In addition, DermACELL will be compared to an active comparator, GraftJacket, in subjects with diabetic foot ulcers.
DermACELL and GraftJacket are both made from donated human skin (dermis). These products have been processed so that cells are removed and bacteria and viruses are destroyed. This processing provided a supporting structure, an acellular dermal matrix, into which cells can migrate and divide during the wound healing process.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- DermACELL, GraftJacket, Conventional Care Dressings
- Keywords
- Diabetic foot ulcer, Venous stasis ulcer, Wound of the lower extremity, Skin substitute, Acellular Dermal Matrix
- Medical subject headings
- Diabetic Foot, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermACELLOther
Also called LifeNet Health Product Code: DCELL112
Acellular dermal matrix is applied at Baseline visit. The study product may be reapplied an additional time (between Weeks 2 and 12 for venous stasis ulcers and between Weeks 3 and 12 for diabetic foot ulcers).
GraftJacketOther
Also called KCI Product Code: GJ44
Acellular dermal matrix applied at Baseline visit. May be reapplied one additional time during study (between Week 2 and 12 for venous stasis ulcers and Week 3 and 12 for diabetic foot ulcers).
Conventional Care DressingsOther
Depending on the state of the wound (dry or moist), different types of nonadherent dressings would be utilized as the primary dressing:
- If the wound is dry, a nonadherent dressing, such an oil emulsion dressing, may be appropriate, as these dressings tend to donate moisture to the wound.
- Hydrogels can also be used if the wound is in need of moisture.
- For a wound that is more moist, a more absorptive dressing may be more appropriate to help reduce potential for maceration.
A secondary dressing may be desired to add either loft or cushion.
| Study group | Role | What they receive |
|---|---|---|
| DermACELL | Experimental | DermACELL acellular dermal matrix will be used to treat subjects diagnosed with an ulcer of the lower extremity (diabetic foot ulcer or venous stasis ulcer). Receives: Other: DermACELL |
| Conventional care dressings | Placebo comparator | Currently accepted standard of care wound management including Conventional care dressings will be utilized in subjects with a diagnosis of either diabetic foot ulcer or venous stasis ulcer. Receives: Other: Conventional Care Dressings |
| GraftJacket | Active comparator | GraftJacket acellular dermal matrix will be used in those subjects diagnosed with a diabetic foot ulcer. Receives: Other: GraftJacket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of DermACELL on the proportion of chronic wounds of the lower extremity that have healed.
The primary outcome is the comparison of the proportion of chronic wounds treated with DermACELL and treated with conventional care that have achieved 100% re-epithelialization without dressing or drainage requirements at 12 weeks. Wound closure is defined as first observation of 100% re-epithelialization without drainage or dressing requirements and complete wound closure is defined as 100% re-epithelialization without dressing or drainage requirements confirmed at two consecutive study visits 2 weeks apart.
Measured: 12 weeks
Secondary outcomes (1)
Proportion of wounds closed at 12 weeks and weekly thereafter for up to 24 weeks
The proportion of subjects with closed wounds at 12 weeks and weekly thereafter will be compared in subjects treated with DermACELL, GraftJacket (Diabetic foot ulcer subjects only) and conventional care wound management. A comparison of the proportion of subjects who received a second application of acellular dermal matrix will be made between the DermACELL and GraftJacket arms in those subjects with diabetic foot ulcers.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeNet Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Moore, Ph.D., Study director, LifeNet Health, Scientific Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970163
- Sponsor's protocol ID
- CR-13-001
- Status last verified
- Mar 2018
- First submitted
- 22 Oct 2013
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Walters J, Cazzell S, Pham H, Vayser D, Reyzelman A. Healing Rates in a Multicenter Assessment of a Sterile, Room Temperature, Acellular Dermal Matrix Versus Conventional Care Wound Management and an Active Comparator in the Treatment of Full-Thickness Diabetic Foot Ulcers. Eplasty. 2016 Feb 4;16:e10. eCollection 2016.
PubMed 26933467Cazzell S, Vayser D, Pham H, Walters J, Reyzelman A, Samsell B, Dorsch K, Moore M. A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator. Wound Repair Regen. 2017 May;25(3):483-497. doi: 10.1111/wrr.12551. Epub 2017 Jun 12.
PubMed 28544150
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled, Open Label Trial of DermACELL in Subjects With Chronic Wounds of the Lower Extremities
- ClinicalTrials.gov ID
- NCT01970163
- Acronym / sponsor ID
- CR-13-001
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic foot ulcer, Venous stasis ulcer, Wound of the lower extremity, Skin substitute, Acellular Dermal Matrix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- LifeNet HealthIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Oct 2013 (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.
The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).
Detailed description
This study is designed to demonstrate the effectiveness of DermACELL in the treatment of chronic wounds of the lower extremities. DermACELL will be compared to conventional care in both subjects with diabetic foot ulcers (DFU) and subjects with venous stasis ulcers (VSU). In addition, DermACELL will be compared to an active comparator, GraftJacket, in subjects with diabetic foot ulcers.
DermACELL and GraftJacket are both made from donated human skin (dermis). These products have been processed so that cells are removed and bacteria and viruses are destroyed. This processing provided a supporting structure, an acellular dermal matrix, into which cells can migrate and divide during the wound healing process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DermACELL | Experimental | Other: DermACELLDermACELL acellular dermal matrix will be used to treat subjects diagnosed with an ulcer of the lower extremity (diabetic foot ulcer or venous stasis ulcer). |
| Conventional care dressings | Placebo comparator | Other: Conventional Care DressingsCurrently accepted standard of care wound management including Conventional care dressings will be utilized in subjects with a diagnosis of either diabetic foot ulcer or venous stasis ulcer. |
| GraftJacket | Active comparator | Other: GraftJacketGraftJacket acellular dermal matrix will be used in those subjects diagnosed with a diabetic foot ulcer. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female between the ages of 21 and 80 that are able to provide informed consent, are available for weekly clinic visits and are willing to comply with off-loading requirements of treatment;
- If diabetic, have been on a stable dose of medication to treat diabetes for less than 30 days;
- Have a DFU that has been present for at least 30 days or have a VSU that has been present for at least 60 days;
Key exclusion criteria (11 listed)
- Have a DFU or VSU that is infected;
- Are pregnant or lactating;
- Have an allergy or are sensitive to one of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin;
- Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol;
- Have had a HbA1c level greater than 12% within the past 90 days;
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 |
|---|---|---|
| DermACELLAlso: LifeNet Health Product Code: DCELL112Acellular dermal matrix is applied at Baseline visit. The study product may be reapplied an additional time (between Weeks 2 and 12 for venous stasis ulcers and between Weeks 3 and 12 for diabetic foot ulcers). | Other | DermACELL |
| GraftJacketAlso: KCI Product Code: GJ44Acellular dermal matrix applied at Baseline visit. May be reapplied one additional time during study (between Week 2 and 12 for venous stasis ulcers and Week 3 and 12 for diabetic foot ulcers). | Other | GraftJacket |
| Conventional Care DressingsDepending on the state of the wound (dry or moist), different types of nonadherent dressings would be utilized as the primary dressing: * If the wound is dry, a nonadherent dressing, such an oil emulsion dressing, may be appropriate, as these dressings tend to donate moisture to the wound. * Hydrogels can also be used if the wound is in need of moisture. * For a wound that is more moist, a more absorptive dressing may be more appropriate to help reduce potential for maceration. A secondary dressing may be desired to add either loft or cushion. | Other | Conventional care dressings |
Primary outcome
Effect of DermACELL on the proportion of chronic wounds of the lower extremity that have healed.
Time frame: 12 weeks
The primary outcome is the comparison of the proportion of chronic wounds treated with DermACELL and treated with conventional care that have achieved 100% re-epithelialization without dressing or drainage requirements at 12 weeks. Wound closure is defined as first observation of 100% re-epithelialization without drainage or dressing requirements and complete wound closure is defined as 100% re-epithelialization without dressing or drainage requirements confirmed at two consecutive study visits 2 weeks apart.
1 secondary outcome
Proportion of wounds closed at 12 weeks and weekly thereafter for up to 24 weeks
Time frame: 24 weeks
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 14 Mar 2018.
- Results publication: PubMed 26933467Walters J, Cazzell S, Pham H, Vayser D, Reyzelman A. Healing Rates in a Multicenter Assessment of a Sterile, Room Temperature, Acellular Dermal Matrix Versus Conventional Care Wound Management and an Active Comparator in the Treatment of Full-Thickness Diabetic Foot Ulcers. Eplasty. 2016 Feb 4;16:e10. eCollection 2016.
- Results publication: PubMed 28544150Cazzell S, Vayser D, Pham H, Walters J, Reyzelman A, Samsell B, Dorsch K, Moore M. A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator. Wound Repair Regen. 2017 May;25(3):483-497. doi: 10.1111/wrr.12551. Epub 2017 Jun 12.
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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.
Mark Moore, Ph.D. study director
LifeNet Health, Scientific Affairs
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DermACELL, GraftJacket and Conventional Care Dressings in people with Diabetic Foot Ulcer, run by LifeNet Health at 12 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 3 inclusion and 11 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 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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.
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?
Effect of DermACELL on the proportion of chronic wounds of the lower extremity that have 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?
On the ClinicalTrials.gov record for NCT01970163, which also lists 2 linked publications.
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 14 Mar 2018.