Comparative Effectiveness of Two Acellular Matrices (Dermacell vs. Integra) for Management of Deep Diabetic Foot Ulcers

• ClinicalTrials.gov Identifier: NCT03476876
• Recruitment Status: Recruiting
• First Posted: March 26, 2018
• Last Update Posted: April 23, 2021
• Sponsor: Baylor College of Medicine
• Collaborator: LifeNet Heath
• Information provided by (Responsible Party): Bijan Najafi, PhD, Baylor College of Medicine

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Diabetic Foot Ulcer; Deep Diabetic Foot Ulcer	Device: Dermacell; Device: Integra	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The investigators will randomize using 1-1 ratio and based on wound 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 (Participant)
• Masking Description: Both of acellular dermal matrices are considered as a standard of care for deep wound. The subject will be unaware of type of matrices.
• Primary Purpose: Treatment
• Official Title: Comparative Effectiveness of Two Acellular Matrices (Dermacell vs. Integra) for Management of Deep Diabetic Foot Ulcers - A Randomized Clinical Trial
• Actual Study Start Date: April 2, 2018
• Estimated Primary Completion Date: March 15, 2022
• Estimated Study Completion Date: March 15, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dermacell; Subject will receive treatment for deep diabetic foot ulcer using Dermacell acellular matrix. Subject will be followed for 16 weeks post treatment.	Device: Dermacell; Subject will receive treatment for deep diabetic foot ulcer using Dermacell acellular matrix. Subject will be followed for 16 weeks post treatment.
Active Comparator: Integra; Subject will receive treatment for deep diabetic foot ulcer using Integra acellular matrix. Subject will be followed for 16 weeks post treatment.	Device: Integra; Subject will receive treatment for deep diabetic foot ulcer using Integra acellular matrix. Subject will be followed for 16 weeks post treatment.

Outcome Measures

Primary Outcome Measures :

1. wound size change from Baseline to 8 weeks and 16 weeks [ Time Frame: Baseline, 8 weeks, 16 weeks. ]
   Wound size will be quantified using Aranz Medical Image processing system
2. Time to reach successful granulation from baseline to 16 weeks [ Time Frame: 16 weeks ]
   Granulation will be assessed by treating physician
3. Incidence of complication from baseline to 16 weeks [ Time Frame: 16 weeks ]
   Complication is described as amputation, infection, rejection, need re-application
4. Change in skin perfusion from baseline to 16 weeks [ Time Frame: Baseline to 16 weeks ]
   Skin perfusion will be quantified by ABI and Skin Perfusion Pressure Test (SPP) using Sensilase PAD-IQ (VASAMED) at the lower extremities at baseline and 16 weeks
5. Duration of application [ Time Frame: Baseline at the time of application ]
   Duration of application will be measured by the research coordinator using a stopwatch by timing the preparation and timing the application.

Secondary Outcome Measures :

1. Patient experience and perception of comfort at every week [ Time Frame: From date of randomization until the 16 weeks or date of closure. ]
   Patient experience and perception of comfort will be assessed using a technology acceptance model using Likert scale survey. Maximum score is 65 and minimum score is 13.
2. Perception of pain by subject at every week [ Time Frame: From date of randomization until the 16 weeks or date of closure. ]
   Perception of pain by subject at every week using an analog scale. Scale indicates 0 as no pain and 10 as worst pain.
3. Cost of treatment [ Time Frame: From date of randomization until the 16 weeks or date of closure. ]
   The cost of treatment will be estimated based on inpatient cost (e.g. the duration of operation room utilization, time needed for preparation, duration of application of matrix, etc), wound treatment cost (e.g. number of outpatient visit, number of dressing change, clinician time for dressing changes, facility cost, antibiotics, diagnostic and laboratory test, special equipment, etc), costs association with adverse events, patient out of pocket payments (e.g. transport, medication for management of pain, sleep, etc), and patient/carer lost work time.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 18 years or older
• Non-infected deep wounds (Grade 2 Wagner Ulcer Classification)

Exclusion Criteria:

• 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

Contacts and Locations

Contacts

Contact: Bijan Najafi, PhD; 713-798-7536; bijan.najafi@bcm.edu

Contact: Ana Enriquez, B.S.; 713-798-7537; ana.enriquez@bcm.edu

Locations

United States, Texas

Baylor College of Medicine; Recruiting

Houston, Texas, United States, 77030

Contact: Bijan Najafi, PhD 713-798-7536 bijan.najafi@bcm.edu

Contact: Ana Enriquez, BS 713-798-7537 ana.enriquez@bcm.edu

Sponsors and Collaborators

Baylor College of Medicine

LifeNet Heath

More Information

• Responsible Party: Bijan Najafi, PhD, Professor of Surgery, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT03476876
• Other Study ID Numbers: H-42282
• First Posted: March 26, 2018
• Last Update Posted: April 23, 2021
• Last Verified: April 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Bijan Najafi, PhD, Baylor College of Medicine:

acellular matrix

Additional relevant MeSH terms:

Diabetic Foot; Foot Ulcer; Ulcer; Pathologic Processes; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases