Status:
UNKNOWN
A Study Measuring the Effectiveness of Combined Modulated Ultrasound and Electric Current Stimulation as an Adjunctive Treatment in Treating Diabetic Foot Ulcers
Lead Sponsor:
Royal College of Surgeons, Ireland
Collaborating Sponsors:
Jagmed Limited
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study aims to investigate if combined modulated ultrasound and electric current stimulation (CUSECS) is an effective adjunctive treatment to use to treat diabetic foot ulcers when compared against...
Detailed Description
Study Background: Diabetes is predicted to be one of the greatest challenges for individuals and society as a whole into the future. Persons with diabetes are 50 times more likely to develop a foot u...
Eligibility Criteria
Inclusion
- Participants must be a diagnosed diabetic.
- Participants who have the capacity to provide informed consent prior to participation in the study.
- Participants must be aged 18 or over on the day of the informed consent.
- Participants have an ulcer that has been present for at least 60 and less than 365 days.
- Participants and/or caregiver must be willing and able to comply with all study procedures and scheduled follow-up visits, for the duration of the study.
Exclusion
- Subjects without capacity to consent or those who do not provide informed consent.
- Ulcers that have a total surface area greater than 15 cm2 as measured by a member of the study staff.
- Unwilling to continue with their standard wound care therapy for the study duration.
- Clinical evidence of infection or gangrene on any part of the affected foot or leg. A subject with clinically infected wound(s) who otherwise meets the study criteria may enter the study after successful treatment of the for wound infection.
- Target ulcer involving exposure of tendon, bone or joint capsule, or any tunnelling or sinus tracts (it is acceptable to have ulcers extending through the dermis and into subcutaneous tissue with presence of granulation tissue).
- Target ulcer treatment with a wound dressing containing human growth factors, engineering tissues, or skin substitutes (e.g. Apligraf, Dermagraf, Regranex etc) within 30 days of screening visit or planned during the study duration.
- History of bone cancer or metastatic disease of the affected limb, radiation therapy to the affected limb, or chemotherapy within the 12 months prior to screening visit.
- Suspected or confirmed malignancy of the wound.
- Participation in another drug or device study for the treatment of diabetic foot ulcer within 30 days of screening visit.
- Vascular procedures performed within 30 days of screening visit.
- Active bleeding tissue or untreated haemorrhagic conditions.
- Active or suspected DVT or thrombophlebitis.
- Conditions which, in the judgment of the treating investigator, may severely compromise the subject's ability to complete the study.
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03458286
Start Date
April 1 2018
End Date
October 1 2018
Last Update
March 8 2018
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