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

Celleration

Status and phase

Terminated

Phase 4

Conditions

Diabetic Foot Ulcer

Treatments

Device: MIST Therapy

Other: SOC - Standard of Care

Study type

Interventional

Funder types

Industry

Identifiers

NCT01608776

CR-86036

Details and patient eligibility

About

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).

Enrollment

13 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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