Diabetic Foot UlcerPhase 2/3NCT03476876
Comparative Effectiveness of Two Acellular Matrices (Dermacell vs. Integra) for Management of Deep Diabetic Foot Ulcers
A Phase 2/3 study testing Dermacell and Integra in people with Diabetic Foot Ulcer and Deep Diabetic Foot Ulcer, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Diabetes-related foot ulcers (DFUs) are a leading cause of hospitalization and amputation worldwide, and account for 33% of all direct costs of diabetes care in the US. Ulcers requiring acute care can result in treatment costs of up to US$70,000 per event, varying with the severity of the wound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Deep Diabetic Foot Ulcer
- What is being tested?
- Dermacell and Integra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2018to 2 Apr 2021
- Phase
- Phase 2/3
- 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
- 18 years or older
- Non-infected deep wounds (Grade 2 Wagner Ulcer Classification)
Who cannot join
- Minors
- Wounds with bone exposure
- Active infection
- Gangrene or osteomyelitis
- Major vascular problems (ABI <0.5 or >1.3)
- Unable to comply with follow up visits (e.g. long distance travel)
- Unable or unwilling to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effectiveness of Two Acellular Matrices (Dermacell vs. Integra) for Management of Deep Diabetic Foot Ulcers - A Randomized Clinical Trial
Diabetes-related foot ulcers (DFUs) are a leading cause of hospitalization and amputation worldwide, and account for 33% of all direct costs of diabetes care in the US. Ulcers requiring acute care can result in treatment costs of up to US$70,000 per event, varying with the severity of the wound. Once the skin is ulcerated, it is susceptible to becoming infected and ultimately amputation in particular in case of deep DFUs. To manage the cost and avoid hospitalization and amputation, wound should be immediately closed. But this is often challenging in diabetic foot with deep ulcers.Wound healing is a dynamic process involving interactions between cells, extracellular matrix (ECM) and growth factors that reconstitutes tissue following injury. ECM plays an important role in tissue regeneration and is the major component of the dermal skin layer. Recognition of the importance of the ECM in wound healing has led to the development of wound products that aim to stimulate or replace the ECM in particular in case of deep tissue destruction because of deep DFUs. It is known from the literature that chronic or hard-to-heal wounds are characterized by a disrupted or damaged ECM that cannot support wound healing. Thus treatment strategies based on use of biologic scaffold materials for management of chronic and deep wounds has increased dramatically during the past two decades. These scaffolds include those comprising an intact extracellular matrix (ECM) or individual components of the ECM, and those comprising hybrids incorporating a synthetic component with a biologic component. DermACELL (LifeNet Health,Virginia Beach, VA) is acellular dermal matrices (ADM), which has been shown to be effective in treating chronic DFUs in a clinical trial.
Another ADM product available in the market is made by Integra® (Bilayer Matrix Wound Dressing, Integra LifeSciences). However, advantages/disadvantages of one compared to the other are unclear. In addition, prior studies often focused on wound healing outcomes (e.g. time to heal, success of wound healing) without considering patient-centered and physician-centered outcomes such as time and difficulty to apply, likelihood of adverse events and need for reapplication, poor tissue mechanics outcomes (e.g. presence of scarring or tissue biomechanics properties leading to increase in shear or pressure post healing thus increasing likelihood of recurrence of the ulcer), and other patient centered outcomes like smell, pain, and comfort.
The primary objective of this prospective, randomized trial is to compare the outcomes of DermaCELL with Integra. The investigators assumed that the wounds outcomes (e.g. weekly wound size change, time to heal, time to successful wound granulation) are comparable between DermaCELL and Integra. However, from operation and patient centered outcomes, there may be some noticeable differences. For instance, DermaCELL, thanks to its mesh structure, thin thickness, and no need for hydration, may be easier to apply with shorter time than Integra. The factors are of key importance in operation room (OR) setting and could reduce overall cost of application and needs in using OR resources. Other important outcomes least addressed in prior studies are number of grafts failing, adverse events (e.g. amputation, infection, etc), cost of wound healing treatment, tissue biomechanics, which may lead to recurrence of ulcers (e.g. formation of tissue scarring), and other patient-centered outcomes (e.g. pain, quality of sleeping, wound smelling, etc). For instance, many patients are unhappy with smelling of wounds, which make them embarrassed among their family members like grand kids. Thus reducing wound smelling during activities of daily living is often considered as an important patient centered outcomes.
- Conditions
- Diabetic Foot Ulcer, Deep Diabetic Foot Ulcer
- Being tested
- Dermacell, Integra
- Keywords
- acellular matrix
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermacellCombination product
Also called Dermacell acellular dermal matrix placed in one lesion
Subject will receive treatment for one non-healing deep diabetic foot ulcer using one Dermacell acellular matrix. Subject will be followed up to 16 weeks post treatment, or until wound has closed, whichever comes first.
IntegraCombination product
Also called Integra bilayer cross-linked matrix placed in one lesion
Subject will receive treatment for one non-healing deep diabetic foot ulcer using one Integra bilayer cross-linked matrix. Subject will be followed up to 16 weeks post treatment, or until wound has closed, whichever comes first.
| Study group | Role | What they receive |
|---|---|---|
| Dermacell | Experimental | Subject will receive treatment for one non-healing deep diabetic foot ulcer using one Dermacell acellular matrix. Subject will be followed up to 16 weeks post treatment, or until wound has closed, whichever comes first. Receives: Combination Product: Dermacell |
| Integra | Active comparator | Subject will receive treatment for one non-healing deep diabetic foot ulcer using one Integra bilayer cross-linked matrix. Subject will be followed up to 16 weeks post treatment, or until wound has closed, whichever comes first. Receives: Combination Product: Integra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Area at 16 Weeks
Wound area in squared centimeters will be quantified using Aranz Medical Image processing system. The wound will be manually traced using Aranz Medical to obtain length and width. Then the average of wound per group will be compared at 16 weeks.
Measured: An average of 16 weeks.
Percentage of Wound Granulation at 16 Weeks
Percentage of wound granulation will be subjectively assessed based on the observation and criteria of the treating clinician. After cleaning the wound, the clinician will provide with a percentage of granulated tissue based on his/her observation. Then, the average of wound granulation per group will be compared at 16 weeks
Measured: An average of 16 weeks.
Lower Extremity Skin Perfusion at 16 Weeks
Skin perfusion will be quantified by Skin Perfusion Pressure Test (SPP) using Sensilase PAD-IQ (VASAMED) on the lower extremities. This tests utilizes a cuff with sensors placed above the ankle level which measures the lower extremity distal skin perfusion pressure in millimeters of mercury (mmHg) while eliciting and releasing pressure to the vasculature of the lower leg through the cuff. Then, the average of mmHg per group will be compared at 16 weeks.
Measured: An average of 16 weeks.
Wound Saturation of Oxygen at 16 Weeks
Wound saturation of oxygen will be quantified using Near Infrared Spectroscopy by Kent Imaging system. Kent is a non-invasive camera that detects wound saturation of oxygen with a simple spectral picture. After taking the picture, each wound will be traced allowing for accurate and detailed data collection. Then, the average of saturation of oxygen of wounds per group will be compared at 16 weeks.
Measured: An average of 16 weeks.
Secondary outcomes (4)
Number of Participants With Frailty
Frailty assessment will be measured with the Trauma Specific Frailty Index (TSFI) score. The total score of 15 variables including cardiovascular and cognitive comorbidities, and features such as mobility assistance, mood status, physical function, and nutritional status will be taken into consideration to determine whether a patient is frail. The minimum score is 0 and the maximum score is 0.3. A total score (including the 15 variables) of >0.27 is considered as frail. A score of ≤0.27 score is considered as non-frail.
Measured: Only baseline, time of recruitment
Time of Graft Application to One Wound During Baseline Procedure
Duration of graft application will be measured from the time of the graft being placed on the wound, to the time of the last suture/staple to secure the graft placement. Time will be counted in seconds. Then, the average of time per group will be compared to the other group.
Measured: Only at baseline, time of recruitment
Number of Participants With Graft Re-application to One Wound at 16 Weeks
Number of participants in need to re-apply at least one same or different graft(s) to one wound in approximately 16 weeks
Measured: An average of 16 weeks.
Number of Participants With Wound Complications at 16 Weeks
Complication is described as infection, necrosis, bleeding, or graft-rejection of one wound per patient.
Measured: An average of 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start2 Apr 2018
- Primary completion29 Oct 2020
- Study completion2 Apr 2021
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.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will randomize using 1-1 ratio and based on diabetic foot ulcer cases. In the case that a subject had two eligible wound cases, the randomization will be done to have similar probably for the wound location (e.g. forefoot, mid-foot, hind-foot, etc). If an eligible subject had more than two wounds, only one of them will be considered as an intervention and only one of them as a control case.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- LifeNet Health
- Responsible party
- Principal investigator, Bijan Najafi, PhD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476876
- Sponsor's protocol ID
- H-42282
- Status last verified
- Jun 2023
- First submitted
- 7 Mar 2018
- Last updated
- 7 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Two Acellular Matrices (Dermacell vs. Integra) for Management of Deep Diabetic Foot Ulcers - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03476876
- Acronym / sponsor ID
- H-42282
- Conditions
- Diabetic Foot Ulcer, Deep Diabetic Foot Ulcer
- Keywords
- acellular matrix
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- LifeNet Health
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 29 Oct 2020 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Posted 7 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes-related foot ulcers (DFUs) are a leading cause of hospitalization and amputation worldwide, and account for 33% of all direct costs of diabetes care in the US. Ulcers requiring acute care can result in treatment costs of up to US$70,000 per event, varying with the severity of the wound. Once the skin is ulcerated, it is susceptible to becoming infected and ultimately amputation in particular in case of deep DFUs. To manage the cost and avoid hospitalization and amputation, wound should be immediately closed. But this is often challenging in diabetic foot with deep ulcers.Wound healing is a dynamic process involving interactions between cells, extracellular matrix (ECM) and growth factors that reconstitutes tissue following injury. ECM plays an important role in tissue regeneration and is the major component of the dermal skin layer. Recognition of the importance of the ECM in wound healing has led to the development of wound products that aim to stimulate or replace the ECM in particular in case of deep tissue destruction because of deep DFUs. It is known from the literature that chronic or hard-to-heal wounds are characterized by a disrupted or damaged ECM that cannot support wound healing. Thus treatment strategies based on use of biologic scaffold materials for management of chronic and deep wounds has increased dramatically during the past two decades. These scaffolds include those comprising an intact extracellular matrix (ECM) or individual components of the ECM, and those comprising hybrids incorporating a synthetic component with a biologic component. DermACELL (LifeNet Health,Virginia Beach, VA) is acellular dermal matrices (ADM), which has been shown to be effective in treating chronic DFUs in a clinical trial.
Another ADM product available in the market is made by Integra® (Bilayer Matrix Wound Dressing, Integra LifeSciences). However, advantages/disadvantages of one compared to the other are unclear. In addition, prior studies often focused on wound healing outcomes (e.g. time to heal, success of wound healing) without considering patient-centered and physician-centered outcomes such as time and difficulty to apply, likelihood of adverse events and need for reapplication, poor tissue mechanics outcomes (e.g. presence of scarring or tissue biomechanics properties leading to increase in shear or pressure post healing thus increasing likelihood of recurrence of the ulcer), and other patient centered outcomes like smell, pain, and comfort.
The primary objective of this prospective, randomized trial is to compare the outcomes of DermaCELL with Integra. The investigators assumed that the wounds outcomes (e.g. weekly wound size change, time to heal, time to successful wound granulation) are comparable between DermaCELL and Integra. However, from operation and patient centered outcomes, there may be some noticeable differences. For instance, DermaCELL, thanks to its mesh structure, thin thickness, and no need for hydration, may be easier to apply with shorter time than Integra. The factors are of key importance in operation room (OR) setting and could reduce overall cost of application and needs in using OR resources. Other important outcomes least addressed in prior studies are number of grafts failing, adverse events (e.g. amputation, infection, etc), cost of wound healing treatment, tissue biomechanics, which may lead to recurrence of ulcers (e.g. formation of tissue scarring), and other patient-centered outcomes (e.g. pain, quality of sleeping, wound smelling, etc). For instance, many patients are unhappy with smelling of wounds, which make them embarrassed among their family members like grand kids. Thus reducing wound smelling during activities of daily living is often considered as an important patient centered outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The investigators will randomize using 1-1 ratio and based on diabetic foot ulcer cases. In the case that a subject had two eligible wound cases, the randomization will be done to have similar probably for the wound location (e.g. forefoot, mid-foot, hind-foot, etc). If an eligible subject had more than two wounds, only one of them will be considered as an intervention and only one of them as a control case.
| Arm | Type | Receives |
|---|---|---|
| Dermacell | Experimental | Combination Product: DermacellSubject will receive treatment for one non-healing deep diabetic foot ulcer using one Dermacell acellular matrix. Subject will be followed up to 16 weeks post treatment, or until wound has closed, whichever comes first. |
| Integra | Active comparator | Combination Product: IntegraSubject will receive treatment for one non-healing deep diabetic foot ulcer using one Integra bilayer cross-linked matrix. Subject will be followed up to 16 weeks post treatment, or until wound has closed, whichever comes first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Non-infected deep wounds (Grade 2 Wagner Ulcer Classification)
Key exclusion criteria (7 listed)
- Minors
- Wounds with bone exposure
- Active infection
- Gangrene or osteomyelitis
- Major vascular problems (ABI <0.5 or >1.3)
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: Dermacell acellular dermal matrix placed in one lesionSubject will receive treatment for one non-healing deep diabetic foot ulcer using one Dermacell acellular matrix. Subject will be followed up to 16 weeks post treatment, or until wound has closed, whichever comes first. | Combination product | Dermacell |
| IntegraAlso: Integra bilayer cross-linked matrix placed in one lesionSubject will receive treatment for one non-healing deep diabetic foot ulcer using one Integra bilayer cross-linked matrix. Subject will be followed up to 16 weeks post treatment, or until wound has closed, whichever comes first. | Combination product | Integra |
Primary outcome
Wound Area at 16 Weeks
Time frame: An average of 16 weeks.
Wound area in squared centimeters will be quantified using Aranz Medical Image processing system. The wound will be manually traced using Aranz Medical to obtain length and width. Then the average of wound per group will be compared at 16 weeks.
Percentage of Wound Granulation at 16 Weeks
Time frame: An average of 16 weeks.
Percentage of wound granulation will be subjectively assessed based on the observation and criteria of the treating clinician. After cleaning the wound, the clinician will provide with a percentage of granulated tissue based on his/her observation. Then, the average of wound granulation per group will be compared at 16 weeks
Lower Extremity Skin Perfusion at 16 Weeks
Time frame: An average of 16 weeks.
Skin perfusion will be quantified by Skin Perfusion Pressure Test (SPP) using Sensilase PAD-IQ (VASAMED) on the lower extremities. This tests utilizes a cuff with sensors placed above the ankle level which measures the lower extremity distal skin perfusion pressure in millimeters of mercury (mmHg) while eliciting and releasing pressure to the vasculature of the lower leg through the cuff. Then, the average of mmHg per group will be compared at 16 weeks.
Wound Saturation of Oxygen at 16 Weeks
Time frame: An average of 16 weeks.
Wound saturation of oxygen will be quantified using Near Infrared Spectroscopy by Kent Imaging system. Kent is a non-invasive camera that detects wound saturation of oxygen with a simple spectral picture. After taking the picture, each wound will be traced allowing for accurate and detailed data collection. Then, the average of saturation of oxygen of wounds per group will be compared at 16 weeks.
4 secondary outcomes
Number of Participants With Frailty
Time frame: Only baseline, time of recruitment
Time of Graft Application to One Wound During Baseline Procedure
Time frame: Only at baseline, time of recruitment
Number of Participants With Graft Re-application to One Wound at 16 Weeks
Time frame: An average of 16 weeks.
Number of Participants With Wound Complications at 16 Weeks
Time frame: An average of 16 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diabetic Foot Ulcer
Active, not recruitingPhase 4
A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
RecruitingObservational study
Efficacy and Safety of a Nitric Oxide Generating Dressing for Diabetic Foot Ulcers (ONWARD)
Diabetic Foot Ulcers (DFUs)
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dermacell and Integra in people with Diabetic Foot Ulcer and Deep Diabetic Foot Ulcer, run by Baylor College of Medicine 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 2 inclusion and 7 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 7 Jul 2023. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2023). 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?
Wound Area at 16 Weeks (time frame: An average of 16 weeks.). The study lists 4 primary outcomes in all. 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 7 Jul 2023.