Clinical trial NCT03476876: Comparative Effectiveness of Two Acellular Matrices (Dermacell vs. Integra) for Management of Deep Diabetic Foot Ulcers
Official title: Comparative Effectiveness of Two Acellular Matrices (Dermacell vs. Integra) for Management of Deep Diabetic Foot Ulcers - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetic Foot Ulcer
Deep Diabetic Foot Ulcer
Keywords: acellular matrix
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: LifeNet Health
First posted: 2018-03-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Wound Area at 16 Weeks
timeFrame: An average of 16 weeks.
measure: Percentage of Wound Granulation at 16 Weeks
timeFrame: An average of 16 weeks.
measure: Lower Extremity Skin Perfusion at 16 Weeks
timeFrame: An average of 16 weeks.
measure: Wound Saturation of Oxygen at 16 Weeks
timeFrame: An average of 16 weeks.
Secondary outcomes:
measure: Number of Participants With Frailty
timeFrame: Only baseline, time of recruitment
measure: Time of Graft Application to One Wound During Baseline Procedure
timeFrame: Only at baseline, time of recruitment
measure: Number of Participants With Graft Re-application to One Wound at 16 Weeks
timeFrame: An average of 16 weeks.
measure: Number of Participants With Wound Complications at 16 Weeks
timeFrame: An average of 16 weeks.
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: