Diabetic Foot UlcerNCT03044132
DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers
A study testing DermACELL AWM in people with Diabetic Foot Ulcer and Lower Extremity Wound, run by LifeNet Health at 2 sites in United States.
Trial summary
This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes of DermACELL AWM in dermal regeneration. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Diabetic Foot Ulcer, Lower Extremity Wound
- What is being tested?
- DermACELL AWM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2017to 31 Dec 2018
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Wagner Grade 3 or 4 complex soft tissue defect that extends below subcutaneous tissue (exposed fascia, ligament, tendon, muscle, or bone)
- target wound that is either acute or chronic (nonhealing wounds greater than 4 weeks but not greater than 1 year in duration)
- target wound that is not amendable to primary closure
- target wound deemed without any residual infection (as assessed by Investigator) or is being treated upon entry into the clinical trial
- adequate perfusion to the extremity
- laboratory assessments which represent a good potential for wound healing (liver and kidney function, nutritionally stable and diabetes control)
Who cannot join
- untreated infection of soft tissue or bone
- untreated autoimmune connective tissue disorders
- body mass index (BMI) of ≥ 50
- undergoing chemotherapy/radiation therapy or taking an immunosuppressant medication
- active liver disease (e.g. hepatitis A-G),
- have undergone previous wound care therapy that included any bioengineered alternative tissue or STSG 30 days prior to enrollment
Show all 9Show fewer
- pregnant
- enrolled in any other interventional clinical research trial
- an increase or decrease of more than 25% in wound area or volume from the Screening to Baseline visit.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Limb Preservation Platform
Fresno, California, 93710
Purvis Moyer Foot and Ankle Center
Rocky Mount, North Carolina, 27804
About this study
Official title: A Prospective Trial Measuring the Clinical Outcomes for DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers
This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes of DermACELL AWM in dermal regeneration.
Read the detailed description
This clinical evaluation with DermACELL AWM will explore its use in the treatment of complex soft tissue defects involving muscle, fascia, tendon, or bone exposure (Wagner Classification 3 and 4).
A total of 50 subjects will be treated with DermACELL AWM in the operating room for coverage of deep soft tissue defects in the lower extremity. Subjects will then be followed in the outpatient clinic for up to 16 weeks.
The specific aim of the study is to assess the ability of the product to sustain an optimal dermal layer. The time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM) and safety data will be collected.
- Conditions
- Diabetic Foot Ulcer, Lower Extremity Wound
- Being tested
- DermACELL AWM
- Keywords
- Diabetic Foot Ulcer, DFU, Lower Extremity Wound, Skin Substitute
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermACELL AWMOther
Decellularized regenerative human tissue matrix allograft (dermis) processed using proprietary Matracell® technology
| Study group | Role | What they receive |
|---|---|---|
| DermACELL AWM | Experimental | Human acellular dermal matrix (ADM) recovered from human donors, decellularized, provided with at least 97% DNA removal, terminally sterilized in its final package, and ready to use. Receives: Other: DermACELL AWM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM).
Days required for granular bed formation
Measured: 112 Days
Secondary outcomes (3)
Number of applications of study product required to achieve granulation.
Measured: 16 Weeks
Percent wound area reduction and percent complete wound closure at 16 Weeks.
Measured: 16 Weeks
The number of adverse events after DermACELL AWM application including infection, hospitalization, and reoperation.
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start15 Jan 2017
- Primary completion30 Apr 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multicenter post market product evaluation of study product for deep wounds of the lower extremity
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeNet Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044132
- Sponsor's protocol ID
- CR-16-002
- Status last verified
- Sep 2019
- First submitted
- 1 Feb 2017
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cazzell S, Moyer PM, Samsell B, Dorsch K, McLean J, Moore MA. A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix. Adv Skin Wound Care. 2019 Sep;32(9):409-415. doi: 10.1097/01.ASW.0000569132.38449.c0.
PubMed 31361269
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial Measuring the Clinical Outcomes for DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT03044132
- Acronym / sponsor ID
- CR-16-002
- Conditions
- Diabetic Foot Ulcer, Lower Extremity Wound
- Keywords
- Diabetic Foot Ulcer, DFU, Lower Extremity Wound, Skin Substitute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- LifeNet HealthIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 6 Feb 2017 (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 is a prospective, multicenter, clinical research trial evaluating the clinical outcomes of DermACELL AWM in dermal regeneration.
Detailed description
This clinical evaluation with DermACELL AWM will explore its use in the treatment of complex soft tissue defects involving muscle, fascia, tendon, or bone exposure (Wagner Classification 3 and 4).
A total of 50 subjects will be treated with DermACELL AWM in the operating room for coverage of deep soft tissue defects in the lower extremity. Subjects will then be followed in the outpatient clinic for up to 16 weeks.
The specific aim of the study is to assess the ability of the product to sustain an optimal dermal layer. The time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM) and safety data will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multicenter post market product evaluation of study product for deep wounds of the lower extremity
| Arm | Type | Receives |
|---|---|---|
| DermACELL AWM | Experimental | Other: DermACELL AWMHuman acellular dermal matrix (ADM) recovered from human donors, decellularized, provided with at least 97% DNA removal, terminally sterilized in its final package, and ready to use. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Wagner Grade 3 or 4 complex soft tissue defect that extends below subcutaneous tissue (exposed fascia, ligament, tendon, muscle, or bone)
- target wound that is either acute or chronic (nonhealing wounds greater than 4 weeks but not greater than 1 year in duration)
- target wound that is not amendable to primary closure
- target wound deemed without any residual infection (as assessed by Investigator) or is being treated upon entry into the clinical trial
- adequate perfusion to the extremity
Key exclusion criteria (9 listed)
- untreated infection of soft tissue or bone
- untreated autoimmune connective tissue disorders
- body mass index (BMI) of ≥ 50
- undergoing chemotherapy/radiation therapy or taking an immunosuppressant medication
- active liver disease (e.g. hepatitis A-G),
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 |
|---|---|---|
| DermACELL AWMDecellularized regenerative human tissue matrix allograft (dermis) processed using proprietary Matracell® technology | Other | DermACELL AWM |
Primary outcome
Time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM).
Time frame: 112 Days
Days required for granular bed formation
3 secondary outcomes
Number of applications of study product required to achieve granulation.
Time frame: 16 Weeks
Percent wound area reduction and percent complete wound closure at 16 Weeks.
Time frame: 16 Weeks
The number of adverse events after DermACELL AWM application including infection, hospitalization, and reoperation.
Time frame: 16 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 6 Sep 2019.
- Results publication: PubMed 31361269Cazzell S, Moyer PM, Samsell B, Dorsch K, McLean J, Moore MA. A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix. Adv Skin Wound Care. 2019 Sep;32(9):409-415. doi: 10.1097/01.ASW.0000569132.38449.c0.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DermACELL AWM in people with Diabetic Foot Ulcer and Lower Extremity Wound, run by LifeNet Health at 2 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 6 inclusion and 9 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 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM). (time frame: 112 Days). 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 NCT03044132, which also lists 1 linked publication.
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 6 Sep 2019.