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

NCT ID: NCT01608776

Last Updated: 2014-10-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SOC - Standard of Care

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

Group Type: ACTIVE_COMPARATOR

SOC - Standard of Care

Intervention Type: OTHER

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

SOC + MIST Therapy

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

Group Type: ACTIVE_COMPARATOR

MIST Therapy

Intervention Type: DEVICE

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

Interventions

MIST Therapy

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

Intervention Type: DEVICE

SOC - Standard of Care

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• Subject allergic to a broad spectrum of primary & secondary dressing materials, including occlusive dressings and the adhesives on such dressings.
• Female subjects that are pregnant or refuse to utilize adequate contraceptive methods and are of childbearing age during the trial.
• Subject is known to be suffering from a disorder or other situation that the subject or investigator feels would interfere with compliance or other study requirements
• Subject is currently enrolled or has been enrolled in the last 30 days in another investigational device or drug trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celleration, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vickie Driver, DPM

Role: PRINCIPAL_INVESTIGATOR

Locations

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

CR-86036

Identifier Type: -

Identifier Source: org_study_id