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Trial record 11 of 110 for:    Recruiting, Not yet recruiting, Available Studies | "Diabetic Foot"

A Study Measuring the Effectiveness of Combined Modulated Ultrasound and Electric Current Stimulation as an Adjunctive Treatment in Treating Diabetic Foot Ulcers

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ClinicalTrials.gov Identifier: NCT03458286
Recruitment Status : Not yet recruiting
First Posted : March 8, 2018
Last Update Posted : March 8, 2018
Sponsor:
Collaborator:
Jagmed Limited
Information provided by (Responsible Party):
Royal College of Surgeons, Ireland

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 usual care. Consenting patients with diabetic foot ulcers (DFUS) and meet the inclusion criteria will be randomly allocated in to either an experimental group or a control group. The experimental group will receive the adjunctive CUSECS treatment along their usual treatment for their diabetic ulcer. They will be required to attend the Diabetic Foot clinic in St. James's hospital twice a week for a maximum of eight weeks. The CUSECS is provided by attaching small electrodes around the ulcers to provide electric current stimulation. A probe is used on the ulcers to provide the ultrasound waves. Both aiming to increase the blood flow to an area to increase wound healing. The control group will be required to attend the diabetic foot clinic for their usual care for their diabetic foot ulcer once a week for a maximum for eight weeks. Once a week both groups ulcers will be assessed and measured and a photograph solely of the wound will be taken for documentation of wound healing. Wound pain as determined using the 0-10 Numeric pain rating scale will also be measured once a week.

The movement in participant's ankle will be measured (flexion, extension, inversion) at the start and at the end of the study to see if treatment has improved its movement.

As part of this study participants' will also be requested to fill out a SF-36 questionnaire at the start and at the end of the 8 week trial. This questionnaire evaluates a person's health related quality of life in which the research wants to see if it is affected by a diabetic foot ulcer. The self-efficacy of participants will also be assessed using PROMIS® Item Bank v.1.0 - General Self-Efficacy at the start and at the end of the 8 week trial. The cost of treatment for each arm will be calculated taking into account both direct (cost of treatments, consumables etc.) and indirect costs (loss of earnings, travel, parking etc.). Therefore, as part of this study, participants will be asked about mode of transport and transport time to and from the clinic and if their diabetic foot ulcer has affected their ability to work.

Diabetic foot ulcer reoccurrence rates will be monitored in both groups by a follow up appointment 4 weeks after each group completes treatment or monitoring.

Data from both groups will be examined and compared to see if CUSECS is effective in healing DFUs. The primary outcome of interest is wound healing and is determined by the number of wounds healed and the time to complete wound healing within eight weeks. All data will be stored confidentially.

The study hypothesis is that there is be increased healing rates in subjects treated with CUSECS in combination with standard care compared to those treated with standard care alone.

This study aims to provide evidence for continuing improvement in treatment for those suffering with diabetic foot ulcers.


Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Device: BRH-A2 wound healing device Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will be randomly allocated into an experimental arm and a control arm of the study. The experimental group will receive the adjunctive CUSECS treatment along their usual treatment for their diabetic ulcer twice weekly for 8 weeks using the BRH-A2 wound healing device. They will also have a follow up appointment 4 weeks after completion of treatment.

The control group will be required to attend the diabetic foot clinic for their usual care for their diabetic foot ulcer with weekly review for a maximum of eight weeks. They will also have a follow up appointment 4 weeks after completion of treatment.

Masking: Single (Outcomes Assessor)
Masking Description: Analysis of data will be blinded and carried out by a statistician. Patient data will be coded and not identifiable directly. The key to the code book information will be secured separately from the dataset in an encrypted file, which will only be accessible by the researcher and the supervisors of the study. Therefore the each arm will be coded and none identifiable to the outcome assessor.
Primary Purpose: Treatment
Official Title: A Pilot Randomised Control Trial to Measure the Effectiveness of Combined Modulated Ultrasound and Electric Current Stimulation in Treating Diabetic Foot Ulcers
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
The control group will be required to attend the diabetic foot clinic for their usual care for their diabetic foot ulcer with weekly review for a maximum of eight weeks. They will also have a follow up appointment 4 weeks after completion of treatment.
Experimental: Experimental Arm
A device- BRH-A2 wound healing device will provide Combined ultrasound and electric current stimulation (CUSECS) treatment which is the intervention for this arm. Participants in this group will receive an adjunctive combined ultrasound and electric current stimulation (CUSECS) treatment along their usual treatment for their diabetic ulcer twice weekly for 8 weeks using the BRH-A2 wound healing device. They will also have a follow up appointment 4 weeks after completion of treatment.
Device: BRH-A2 wound healing device
Combined ultrasound and electric current stimulation (CUSECS) is a combination therapy provided by the BRH-A2 wound healing device. This study is testing the effectiveness of the treatment CUSECS. The electric current stimulation is provided by attaching small electrodes around the ulcers. A probe is used on the ulcers to provide the ultrasound waves. Both aiming to increase the blood flow to an area to increase wound healing.




Primary Outcome Measures :
  1. Total wound healing [ Time Frame: 8 weeks ]

    The number of wounds that completely heal in the experimental group compared to control group. This may be presented in either or both following formats:

    • The proportion of wounds completely healed (frequency of complete healing by group).
    • The time to complete wound healing.


Secondary Outcome Measures :
  1. Changes in wound bed condition. [ Time Frame: 8 weeks ]
    Wound bed condition will be assessed using the Photographic Wound Assessment Tool (PWAT)

  2. Patient reported quality of life [ Time Frame: 8 weeks ]
    The effect of a DFU on a person's health related quality of life will be evaluated through SF-36 questionnaire.

  3. Wound pain [ Time Frame: 8 weeks ]
    Wound pain as determined using the 0-10 Numeric pain rating scale (NPRS). The NPRS is an 11-point scale from 0-10 with "0" indicating no pain and "10", the most intense pain imaginable. Patients verbally select a value that is most in line with the intensity of pain that they are experiencing.

  4. Self-efficacy [ Time Frame: 8 weeks ]
    Identifying patient self-efficacy will be carried out using the PROMIS® Item Bank v.1.0 - General Self-Efficacy

  5. Cost of treatment per arm (economic analysis direct cost and in-direct costs). [ Time Frame: 8 weeks ]
    Cost of treatment for each arm of the research will be monitored and calculated taking into account both direct (cost of treatments, consumables etc.) and indirect costs (loss of earnings, travel, parking etc.).

  6. Ankle Range of Motion [ Time Frame: 8 weeks ]
    Ankle Range of Motion will be measured in degrees using a goniometer for flexion, extension & inversion

  7. Diabetic foot ulcer reoccurrence rates [ Time Frame: 4 weeks after the treatment trial is completed (16 weeks) ]
    Diabetic foot ulcer reoccurrence rates will be monitored in both groups by a follow up appointment 4 weeks after each group completes treatment or monitoring.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458286


Contacts
Contact: Caoimhe Joyce Hearne, BSc 0876631977 caoimhejoycehearne@rcsi.ie
Contact: Tom O' Connor, DR. tomoconnor@rcsi.ie

Sponsors and Collaborators
Royal College of Surgeons, Ireland
Jagmed Limited
Investigators
Principal Investigator: Tom O' Connor, DR. Royal College of Surgeons in Ireland
Principal Investigator: Declan Patton, DR Royal College of Surgeons in Ireland

Publications:
O'Connor, T. et al. in EWMA (Amsterdam, 2017).
Julious, S. A. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics 4, 287-291, doi:10.1002/pst.185 (2005).
RCSI (2017) Introduction to Clinical Research and Good Clinical Practice Including Integrated Addendum to GCP Guidelines (E6 (R2) Version 4

Responsible Party: Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT03458286     History of Changes
Other Study ID Numbers: DFUCUSECS
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Royal College of Surgeons, Ireland:
Diabetic Foot Ulcers
Chronic
Combined ultrasound and electric current stimulation
Adjunctive therapy

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