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Extracorporeal Shockwave Therapy for Diabetic Foot Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04042285
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : August 1, 2019
Sponsor:
Collaborator:
University of Hull
Information provided by (Responsible Party):
Hull University Teaching Hospitals NHS Trust

Tracking Information
First Submitted Date  ICMJE July 11, 2019
First Posted Date  ICMJE August 1, 2019
Last Update Posted Date August 1, 2019
Actual Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2019)
Wound volume [ Time Frame: Baseline, up to 7 days, 4 weeks, 8 weeks, 12 weeks ]
Change in wound volume between study visits
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2019)
  • Pain Score Questionnaire [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
    Brief Pain Inventory and Visual Analogue Scale
  • Quality of Life Questionnaire [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
    SF-12 and EQ-5Q-3L
  • Infection rate [ Time Frame: Recorded at evey study contact ]
    The number of wounds which develop an infection in the study period
  • Amputation rate [ Time Frame: Recorded at every study contact ]
    The number of amputations of treated sites in the study period
  • Local perfusion rate [ Time Frame: Baseline, up to 7 days ]
    blood flow perfusion rate of superficial tissues using Doppler flowmetry
  • Tissue integrity [ Time Frame: Baseline, up to 7 days ]
    Tissue hydration determined by a vapometer
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extracorporeal Shockwave Therapy for Diabetic Foot Wounds
Official Title  ICMJE Extracorporeal Shockwave Therapy for Diabetic Foot Wounds: A Cohort Study Comparing Extracorporeal Shockwave Therapy to Standard Treatment for Diabetic Foot Wounds
Brief Summary

Diabetic wounds post digital amputation have poor healing in 30-45% of cases, resulting in 75% of patients undergoing a further amputation within the year, despite best wound management.

Extracorporeal shockwave therapy is a promising safe and non invasive treatment that has been shown to improve healing in chronic ulcers and burns by promoting healing and decreasing risk of infection.

The study will recruit patients on a hospital ward who have undergone a toe amputation for a infected non healing diabetic foot ulcer. Participants will be informed about the study, given an patient information sheet and invited to give informed consent.

Consenting participants will undergo shockwave therapy three times in the seven days after their operation, in addition to standard wound care.

Wound measurements, blood perfusion, tissue integrity, quality of life and pain scores will be recorded at baseline, after the third treatment, 4 weeks, 8 weeks and 12 weeks after recruitment to the study.

The study aims to recruit 25 patients.

The results will be compared to a matched retrospective cohort group who received standard wound care.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetic Foot
  • Wound
Intervention  ICMJE
  • Device: Extracorporeal shockwave therapy
    Extracorporeal shockwave therapy will be given at 120 pulses/cm2, penetration 5mm at a dose of 0.1mJ/mm2 at 5 pulses/second. Participants will receive 3 sessions of shockwave therapy in a 7-day period.
  • Other: Standard Wound Care
    dressing changes, negative pressure wound therapy, offloading footwear, debridement, glycaemic control and antibiotics as necessary
Study Arms  ICMJE
  • Active Comparator: Extracorporeal shockwave therapy
    The shockwave therapy will be given at 120 pulses/cm2, penetration 5mm at a dose of 0.1mJ/mm2 at 5 pulses/second (17). Participants will receive 3 sessions of shockwave therapy in a 7-day period. In addition to standard wound care (dressing changes, negative pressure wound therapy, debridement, offloading footwear, glycaemic control and antibiotics, where appropriate).
    Intervention: Device: Extracorporeal shockwave therapy
  • Placebo Comparator: Standard wound care
    Patient with a diabetic foot wound who receive standard wound care, consisting of dressing changes, negative pressure wound therapy, debridement, offloading footwear, glycaemic control and antibiotics, where appropriate.
    Intervention: Other: Standard Wound Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 31, 2019)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of diabetes mellitus
  • Open surgical wound of the foot
  • ABPI >0.8
  • Age greater than 18 years old
  • Able and willing to give written informed consent
  • Be able to adhere to protocol and attend all follow up appointments

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • Current malignancy
  • Allergy to materials used in the treatment
  • Palliative
  • Unable or unwilling to give consent
  • Anticoagulation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Louise H Hitchman, MBBS +44 01482 674643 hylh@hyms.ac.uk
Contact: George E Smith, M.D +44 01482 674643 georgeedsmith@gmail.com
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04042285
Other Study ID Numbers  ICMJE R2158
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hull University Teaching Hospitals NHS Trust
Study Sponsor  ICMJE Hull University Teaching Hospitals NHS Trust
Collaborators  ICMJE University of Hull
Investigators  ICMJE
Principal Investigator: George E Smith, M.D Academic Vascular Surgery Unit
PRS Account Hull University Teaching Hospitals NHS Trust
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP