Extracorporeal Shockwave Therapy for Diabetic Foot Wounds

Not Applicable

Completed

Conditions: Wound
Diabetic Foot

Interventions: Device: Extracorporeal shockwave therapy
Other: Standard Wound Care

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

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Extracorporeal shockwave therapy	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).
Standard wound care	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.

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.
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.
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.
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.