NCT02081352

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2014

Typical duration for phase_4

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

November 5, 2015

Status Verified

November 1, 2015

Enrollment Period

2.3 years

First QC Date

March 5, 2014

Last Update Submit

November 4, 2015

Conditions

Diabetic Foot Ulcers

Keywords

DermisDiabetic foot ulcersSkin substitutesDecellularized

Outcome Measures

Primary Outcomes (1)

  • Incidence of wound closure

    The incidence of full wound closure at or before 12 weeks, where full wound closure is defined as "100% re-epithelialization, without drainage, that has been confirmed at two study visits up to 14 days apart".

    12 weeks

Secondary Outcomes (2)

  • Rate of wound healing

    12 weeks

  • Quality of wound healing

    4 weeks

Other Outcomes (1)

  • Rate of wound healing in crossover arm

    6 weeks

Study Arms (2)

DermaPure™

ACTIVE COMPARATOR

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.

Other: DermaPure™

Standard care

SHAM COMPARATOR

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.

Other: Standard care

Interventions

DermaPure™OTHER

A minimally manipulated human tissue regulated as "human cells, tissues, and cellular and tissue-based products" (HCT/Ps)

DermaPure™
Standard careOTHER
Standard care

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Carl T. Hayden Medical Research Foundation

Phoenix, Arizona, 85012-1892, United States

RECRUITING

Associated Foot & Ankle Specialists

Phoenix, Arizona, 85015, United States

RECRUITING

University of Miami Hospital

Miami, Florida, 33136, United States

RECRUITING

NYU Langone Medical Center

New York, New York, 10016, United States

RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390-8560, United States

RECRUITING

Futuro Clinical Trials, LLC

McAllen, Texas, 78501, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

sheila nicholson

CONTACT

+44 3304303066s.nicholson@tissueregenix.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2014

First Posted

March 7, 2014

Study Start

August 1, 2014

Primary Completion

November 1, 2016

Study Completion

February 1, 2017

Last Updated

November 5, 2015

Record last verified: 2015-11

Locations

US(7)