APT001 Plasma/NO Generator to Treat Diabetic Foot Ulcer in Adults

NCT02356835 | Completed

• 1 other identifier: APT-14-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief Summary

This is a 10-week, randomized, controlled study to evaluate the efficacy and safety of the APT001 plasma and nitric oxide treatment in subjects with a diabetic foot ulcer.

Conditions

Foot Ulcer, Diabetic

Outcome Measures

Primary Outcomes (1)

• Percent change in total wound size

  Change in total wound size using dimensional measurements of the wound and using the Aranz SilhouetteStar + SilhouetteConnect wound assessment device from Baseline to Week 10.

  Baseline to end of Week 10

Secondary Outcomes (2)

• Change in bacterial load

  Baseline to end of Week 5

• Wound pain

  Baseline to end of Week 10

Study Arms (2)

APT001

EXPERIMENTAL

The APT001 is a medical device that generates a plasma flow containing nitric oxide intended to be applied topically to wound sites. The nitric oxide / plasma flow will be directed at the wound site and surrounding skin at a distance of 11.5 to 15 centimeters from the skin surface. Dose will be 10 seconds / cm2 wound surface area. Administration of the therapy will include a 2 cm border around the defined edges of the wound site.

Device: APT001

SHAM

SHAM COMPARATOR

Treatment with a sham device to deliver non-medicated, heated room air to the wound in the same manner and dose as the active treatment device.

Device: SHAM

Interventions

APT001 DEVICE

APT001, is a portable device that uses plasma energy to deliver nitric oxide to the tissues.

Also known as: APT001 Plasma/Nitric Oxide

APT001

SHAM DEVICE

Portable device that uses warmed room air to mimic delivery of the APT001 treatment.

SHAM

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years of age
• Type 1 or 2 diabetes with hemoglobin A1c less than 12%
• ABI ≥ 0.7, palpable pulses and/or biphasic waveform study with Doppler
• Wound size ≥ 1cm2 and ≤ 30cm2 (the first 10 patients enrolled will be limited to a wound size of 7 cm2 or less)

You may not qualify if:

• Have a significant concomitant illness that would adversely affect participation in the study or affect the healing of the wound
• Have a severe infection in the ulcer including the presence of an abscess, cellulitis extending \> 2 cm beyond the ulcer margin, or osteomyelitis
• Have involvement of deeper tissues including bone or tendon
• Be currently receiving steroid medications, chemotherapy, or other medications that might affect healing of the wound
• Have received topical or systemic antimicrobial therapy within 48 hours of screening
• Have a malignancy other than skin cancer currently being treated
• Have substance abuse issues within the 6 months prior to screening
• Is a woman who is pregnant or breast feeding
• Has been treated with another investigational product within 30 days of screening
• Has been treated with tissue engineered skin or a biological therapy within 30 days of screening

Sponsors & Collaborators

• Origin Inc.: lead

Study Sites (4)

Baptist Health Institute for Advanced Wound Care

Montgomery, Alabama, 36111, United States

Location

Limb Preservation Platform, Inc.

Fresno, California, 93720, United States

Location

Limb Preservation Platform, Inc.

Fresno, California, 93721, United States

Location

New York College of Podiatric Medicine

New York, New York, 10035, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

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

Study Officials

• David R Dantzker, MD

  Origin Inc.

  STUDY DIRECTOR

• Terry A Treadwell, MD

  Institute for Advanced Wound Care Baptist Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 5, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

US (4)