A Comparative Efficacy Study of DermaPure™ to Treat Diabetic Foot Ulcers

TRx Wound Care

Status and phase: Unknown; Phase 4

Conditions: Diabetic Foot Ulcers

Treatments: Other: Standard care; Other: DermaPure™

Study type: Interventional

Funder types: Industry

Identifiers

NCT02081352

TRG-H01-01

Details and patient eligibility

About

This study has been designed to help determine how safe and effective DermaPure™ may be in treating hard-to-heal diabetic foot ulcers compared to the current standard of care.

Full description

DermaPure™ is a decellularized dermal skin substitute using the Tissue Regenix dCELL® patented Technology to remove cells and other components from human and animal tissue while maintaining the native structural and biomechanical properties. The primary objective of the study is to establish the wound healing performance and safety of DermaPure™ over a 12 week period, when administered to "hard to heal" chronic, neuropathic diabetic foot ulcers. This study has been designed to compare the performance of DermaPure™ (in combination with standard care) versus standard care alone.

Enrollment: 50 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 or Type 2 diabetes with HbA1c ≤12%
• Adequate perfusion
• A full thickness chronic, neuropathic diabetic foot plantar ulcer defined by Texas or Wagner classification.
• Target ulcer decreases in size (surface area) by less than 30% in the 2 week screening period.

Exclusion criteria

• BMI greater than 45kg/m2.
• Presence of infection
• Presence of necrosis, purulence or sinus tracts that cannot be removed by aggressive debridement.
• A clinical diagnosis of an active/acute Charcot neuroarthropathy. Inactive/chronic Charcot does not exclude the patient.
• Therapy with any investigational agent or drug within 4 weeks preceding the screening visit.
• More than 2 weeks treatment with immunosuppressive agents within 3 months of enrollment.
• Evidence of malnutrition as confirmed by serum pre-albumin level at screening.
• Evidence of drug or alcohol abuse,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

DermaPure™

Active Comparator group

Description:

DermaPure™ in combination with standard care comprising surgical debridement, covered by a non-adherent silicone wound contact layer, a wound cavity filler (if required), a secondary foam wound dressing and appropriate off-loading footwear.

Treatment:

Other: DermaPure™

Standard care

Sham Comparator group

Description:

Standard care comprising surgical debridement, covered by a non-adherent silicone wound contact layer, a wound cavity filler (if required), a secondary foam wound dressing and appropriate off-loading footwear.

Treatment:

Other: Standard care