Extracorporeal Shockwave Therapy for Diabetic Foot Wounds
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|ClinicalTrials.gov Identifier: NCT04042285|
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : August 1, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Wound||Device: Extracorporeal shockwave therapy Other: Standard Wound Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Extracorporeal Shockwave Therapy for Diabetic Foot Wounds: A Cohort Study Comparing Extracorporeal Shockwave Therapy to Standard Treatment for Diabetic Foot Wounds|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
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).
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.
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.
Other: Standard Wound Care
dressing changes, negative pressure wound therapy, offloading footwear, debridement, glycaemic control and antibiotics as necessary
- Wound volume [ Time Frame: Baseline, up to 7 days, 4 weeks, 8 weeks, 12 weeks ]Change in wound volume between study visits
- 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
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): NCT04042285
|Contact: Louise H Hitchman, MBBS||+44 01482 email@example.com|
|Contact: George E Smith, M.D||+44 01482 firstname.lastname@example.org|
|Hull and East Yorkshire Hospitals NHS Trust||Recruiting|
|Hull, United Kingdom, HU3 2JZ|
|Contact: Louise Hitchman, MBBS 01482 674643 email@example.com|
|Principal Investigator:||George E Smith, M.D||Academic Vascular Surgery Unit|