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

Status unconfirmed · Phase 4

Conditions studied: Diabetic Foot Ulcers

In brief

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.

Key facts

Study ID

NCT02081352

Run by

TRx Wound Care Limited

People needed

50

Starts

2014-08-01

Expected to finish

2017-02-01

Last updated by the study team

2015-11-05

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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,

Where it is running

• Carl T. Hayden Medical Research Foundation — Phoenix, Arizona, United States (enrolling)
• Associated Foot & Ankle Specialists — Phoenix, Arizona, United States (enrolling)
• University of Miami Hospital — Miami, Florida, United States (enrolling)
• NYU Langone Medical Center — New York, New York, United States (enrolling)
• University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
• UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Futuro Clinical Trials, LLC — McAllen, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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