RESPOND Restoring Equilibrium and Wound Stimulation to Promote Healing Of Non-healing DFUs

NCT01608776 | Terminated Phase 4 DMC

• 1 other identifier: CR-86036
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and effectiveness of MIST Therapy in conjunction with Standard of Care (SOC) compared to Standard of Care alone in the treatment of diabetic foot ulcers (DFU).

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Wound Reduction

  Compare between the treatment groups the index wound area percent reduction, calculated as the difference in cm2 of the randomization measurement to the post four weeks of study treatment measurement.

  12 weeks post randomization

Study Arms (2)

SOC - Standard of Care

ACTIVE COMPARATOR

Wound cleansing and debridement as needed, moist wound healing dressing, and off-loading

Other: SOC - Standard of Care

SOC + MIST Therapy

ACTIVE COMPARATOR

Wound cleansing and debridement as needed, moist wound healing dressing, off-loading, and MIST treatment

Device: MIST Therapy

Interventions

MIST Therapy DEVICE

The MIST Therapy System is used as a non-contact method of delivering ultrasound to treat chronic wounds.

SOC + MIST Therapy

SOC - Standard of Care OTHER

Standard of Care includes wound cleansing and debridement as needed, moist wound healing dressings, and offloading

SOC - Standard of Care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject of any race and at least 18 to 90 years old
• Lower extremity full thickness diabetic foot ulcer of 30-364 days duration
• Subject's wound must be between 2cm² and 20cm² at screening
• Subject's wound must be at or below the malleolus
• Documented ABI is between 0.8 and 1.2 on the study limb or transcutaneous partial pressure oxygen (TcpO2) \> 40 mmHG; or a toe pressure \> 40 mmHG; or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) within 30 days of screening.
• Subject or subject's legally authorized representative understands the nature of the procedure(s) and provides written informed consent prior to study enrollment
• Subject is willing and able to comply with all specified care and visit requirements
• Subject and/or caregiver must be willing and able to learn and perform the duties of dressing changes, and demonstrate the ability to do so.

You may not qualify if:

• Index ulcer wound has exposed tendons, ligaments, muscle, or bone
• Index ulcer wound presents with clinical signs of acute infection, suspected or known
• Subjects with evidence of osteomyelitis or cellulitis or gangrene in the study limb
• Subjects with active Charcot's foot on the study limb
• Subjects with amputation above a Trans Metatarsal Amputation (TMA) in the affected limb
• Subjects with active malignancy on the study limb except non-melanoma skin cancer
• Subjects with planned vascular surgery, angioplasty or thrombolysis procedures within the study period
• Subjects within 6 weeks post-operatively of a vascular procedure.
• Subject has had prior skin replacement, negative pressure therapy, or ultrasound therapy applied to the index wound in the 14 days prior to screening
• Subjects who have received oral, or IV antibiotic/antimicrobial agents or medications have been used within 2 days (48 hours) of baseline.
• Subjects who have received topical antibiotic/antimicrobial agents or dressings at the index wound site within 2 days (48 hours) of baseline.
• Subjects currently taking steroids of \>10mg dosage
• Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within 14 days of screening date.
• Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
• Subject has one or more medical condition(s), uncontrolled diabetes (HbA1c \> 12), renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the subject an inappropriate study candidate

Sponsors & Collaborators

• Celleration, Inc.: lead

Study Sites (1)

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, 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

• Vickie Driver, DPM

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: May 31, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: October 8, 2014

Record last verified: 2014-10

Locations

US (1)