Extracorporeal Shockwave Therapy for Diabetic Foot Wounds

Study Overview
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Brief Summary
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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.

Official Title
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Extracorporeal Shockwave Therapy for Diabetic Foot Wounds: A Cohort Study Comparing Extracorporeal Shockwave Therapy to Standard Treatment for Diabetic Foot Wounds

Conditions
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Diabetic Foot, Wound

Intervention / Treatment
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* Device: Extracorporeal shockwave therapy
* Other: Standard Wound Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extracorporeal shockwave therapy<br>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<br>* 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.<br>|
| Placebo Comparator: Standard wound care<br>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<br>* dressing changes, negative pressure wound therapy, offloading footwear, debridement, glycaemic control and antibiotics as necessary<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound volume | Change in wound volume between study visits | Baseline, up to 7 days, 4 weeks, 8 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score Questionnaire | Brief Pain Inventory and Visual Analogue Scale | Baseline, 4 weeks, 8 weeks, 12 weeks | 
| Quality of Life Questionnaire | SF-12 and EQ-5Q-3L | Baseline, 4 weeks, 8 weeks, 12 weeks | 
| Infection rate | The number of wounds which develop an infection in the study period | Recorded at evey study contact | 
| Amputation rate | The number of amputations of treated sites in the study period | Recorded at every study contact | 
| Local perfusion rate | blood flow perfusion rate of superficial tissues using Doppler flowmetry | Baseline, up to 7 days | 
| Tissue integrity | Tissue hydration determined by a vapometer | Baseline, up to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot Wound