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

This study has been terminated.
(Enrollment delays, business re-allocation of resources)
Sponsor:
Information provided by (Responsible Party):
Celleration, Inc.
ClinicalTrials.gov Identifier:
NCT01608776
First received: May 29, 2012
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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).


Condition Intervention Phase
Diabetic Foot Ulcer
Device: MIST Therapy
Other: SOC - Standard of Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Restoring Equilibrium and Wound Stimulation to Promote Healing Of Non-healing DFUs

Resource links provided by NLM:


Further study details as provided by Celleration, Inc.:

Primary Outcome Measures:
  • Wound Reduction [ Time Frame: 12 weeks post randomization ] [ Designated as safety issue: No ]
    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.


Enrollment: 13
Study Start Date: May 2012
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608776

Locations
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Celleration, Inc.
Investigators
Principal Investigator: Vickie Driver, DPM
  More Information

No publications provided

Responsible Party: Celleration, Inc.
ClinicalTrials.gov Identifier: NCT01608776     History of Changes
Other Study ID Numbers: CR-86036
Study First Received: May 29, 2012
Last Updated: October 6, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Diseases
Leg Ulcer
Skin Diseases
Skin Ulcer
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014