Extracorporeal Shockwave Therapy for Diabetic Foot Wounds
- Conditions
- WoundDiabetic Foot
- Registration Number
- NCT04042285
- Lead Sponsor
- Hull University Teaching Hospitals NHS Trust
- 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 and outpatient departments who have a diabetic foot wound. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Diagnosis of diabetes mellitus
- Open 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
- Pregnancy or breast-feeding
- Current malignancy
- Allergy to materials used in the treatment
- Palliative
- Unable or unwilling to give consent
- Anticoagulation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wound Volume 12 weeks Change in wound volume between study visits
- Secondary Outcome Measures
Name Time Method Pain Questionnaire 12 weeks Brief Pain Inventory (BPI) - A person rates their pain on a scale of 0 to 10. The BPI scale defines pain as follows: Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
Quality of Life Questionnaires SF-12 12 weeks Quality of Life Questionnaire Short Form-12 (8 domains of questions) scored on a scale 1-5, where a low score is good health and a high score is poor health. Total scores range from 0 to100, with higher scores indicating better physical and mental health functioning.
Local Perfusion Rate 7 days Blood flow perfusion rate of superficial tissues using Doppler flowmetry, an increase in the number signifies an increase in bloodflow to the area. Doppler flowmetry measures the shift in frequency that occurs when light is scattered by the red blood cells moving through capillaries.
Tissue Integrity 7 days Tissue hydration determined by a vapometer, the sensor evaluates the efficiency of the human skin water barrier, a high score is a sign of increased tissue water loss, and therefore reduced tissue integrity.
Infection Rate Recorded at 12 weeks The number of wounds which develop an infection in the study period.
Minor Amputation Rate Recorded at 12 weeks The number of minor amputations of treated limbs in the study period.
Quality of Life Questionnaire EQ5D3L 12 weeks The EuroQoL-5D-5L is a brief, multiattribute, generic, health status measure composed of 5 questions with Likert response options. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state.
Trial Locations
- Locations (1)
Hull and East Yorkshire Hospitals NHS Trust
🇬🇧Hull, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust🇬🇧Hull, United Kingdom