EZCast-DFU Study With Portal for Application of Topical Medications

NCT02131961 | Completed Phase 1

• 1 other identifier: 20140171
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the ability to modify a contact cast system so that topical medications can be applied daily to an underlying wound in patients with diabetic plantar ulcers. The modification of the cast will be done by making an opening where the wound is located in the contact cast system. A contact cast system is a device that will reduce the pressure in the area where the wound is located.

Conditions

Foot Ulcer; Diabetic Foot

Keywords

diabetic foot; foot ulcer; foot wound; plantar ulcer; plantar wound; contact cast; collagenase

Outcome Measures

Primary Outcomes (1)

• Proportion of contact cast systems intact by day 14

  Proportion of contact cast systems in whom the investigator assesses as intact (not damaged, or broken by the creation of the window). Intact: Contact cast systems where the window creation did not create unintended fissures or these fissures were less than 1cm length and they originate from the window opening. Damaged: Contact cast systems where window creation creates one or more fissure between 1-3cm of length and these fissures originate from the window opening. Broken: Contact cast systems where window creation creates one or more fissures of length more than 3 cm, or any fissure that did not originate from the site of the window opening

  14 days

Study Arms (1)

Study arm

EXPERIMENTAL

Collagenase ointment topical application, once daily for 14 days, modified Contact Cast System, applied at days 0,3, and 7.

Drug: Collagenase ointment; Device: Modified Contact Cast System

Interventions

Collagenase ointment DRUG

250 collagenase units/g

Also known as: Santyl

Study arm

Modified Contact Cast System DEVICE

1 Unit

Also known as: Modified TCC-EZ(R) Total Contact Cast System

Study arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females between 18 and 80 years of age (inclusive) with diabetes type 1 or type 2
• Patients must sign an informed consent
• Diabetic medications must be stable for 4 weeks prior to randomization.
• Patients with a plantar ulcer
• Ulcer with an area between ≥ 1 cm2 and ≤ 10 cm2
• Patients must agree to comply with at least daily dressing changes and off-loading according to protocol requirements;
• Ulcer at least 6 weeks but not more than 12 months old
• Diabetic patients who use a medication to lower blood glucose levels who, in the opinion of the investigator, are considered "controlled" diabetics
• Adequate perfusion of the foot with the ulcer
• No prior use of Santyl on the target ulcer or treatment within one month with other bioactive therapies

You may not qualify if:

• Patients with more than two ulcers on the same foot
• Patients with ulcer requiring off-loading that cannot be effectively off-loaded
• Patients with ulcer above the plantar foot;
• Patient non-compliance with protocol-required off-loading and dressing change
• Patients with infected ulcers
• Patients with severe edema (defined as inability to fit leg into off-loading device);
• Patients with a gangrenous or ischemic toe that may need to be amputated in the opinion of the investigator;
• Patients with Buerger's disease, vasculitis or connective tissue disease;
• Ankle brachial index \>1.2 (ABI \>1.2 must be confirmed by another method such as Transcutaneous partial pressure oxygen (TcPO2) \> 40 mm Hg at the ankle or Toe pressure of \> 40mm Hg or Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic) or Skin Perfusion Pressure (SPP) \> 40 mm Hg);
• Patients with claudication
• Body mass index (BMI) \> 40 kg/m2
• There is active Charcot's joint by clinical or radiographic criteria.
• Unable or unwilling to provide informed consent.
• Known HIV infection and/or AIDS based on participant self-report.
• Patients with contraindication to contact casting (ie. peripheral vascular disease, Infection)

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami, University of Miami Hospital & Clinics

Miami, Florida, 33136, United States

Location

Related Links

• Wound Research Clinic. University of Miami

MeSH Terms

Conditions

Foot Ulcer; Diabetic Foot; Foot Injuries

Interventions

Collagenases

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Study Officials

• Robert S Kirsner, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Vice Chairman Department of Dermatology & Cutaneous Surgery

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: May 6, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 10, 2015

Record last verified: 2015-06

Locations

US (1)