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

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

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).

Study Overview

• Status: Terminated
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Other: SOC - Standard of Care; Device: MIST Therapy

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SOC - Standard of Care; Wound cleansing and debridement as needed, moist wound healing dressing, and off-loading	Other: SOC - Standard of Care; Standard of Care includes wound cleansing and debridement as needed, moist wound healing dressings, and offloading
Active Comparator: SOC + MIST Therapy; Wound cleansing and debridement as needed, moist wound healing dressing, off-loading, and MIST treatment	Device: MIST Therapy; The MIST Therapy System is used as a non-contact method of delivering ultrasound to treat chronic wounds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Celleration, Inc.
• Investigators: Principal Investigator: Vickie Driver, DPM

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: May 29, 2012
• First Submitted That Met QC Criteria: May 30, 2012
• First Posted (Estimate): May 31, 2012

Study Record Updates

• Last Update Posted (Estimate): October 8, 2014
• Last Update Submitted That Met QC Criteria: October 6, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: CR-86036