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| Name | Class |
|---|---|
| University of Hull | OTHER |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal shockwave therapy in addition to standard care | Device | 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. Standard care as per the NICE and IWGDF guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Volume | Change in wound volume between study visits | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Questionnaire | 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. | 12 weeks |
| Quality of Life Questionnaires SF-12 |
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Inclusion Criteria:
Exclusion Criteria:
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Diabetic patients with a foot wound
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| Name | Affiliation | Role |
|---|---|---|
| George E Smith, M.D | Academic Vascular Surgery Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hull and East Yorkshire Hospitals NHS Trust | Hull | HU3 2JZ | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
These are patients with a diabetic foot wound who meet the eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wound Volume | Change in wound volume between study visits | Posted | Mean | 95% Confidence Interval | cm^3 | 12 weeks |
|
12 week adverse event rate.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Louise Hitchman | Hull University Teaching Hospitals NHS Trust | 01482 311925 | l.hitchman@nhs.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2019 | May 13, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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|
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. |
| 12 weeks |
| Infection Rate | The number of wounds which develop an infection in the study period. | Recorded at 12 weeks |
| Minor Amputation Rate | The number of minor amputations of treated limbs in the study period. | Recorded at 12 weeks |
| Local Perfusion Rate | 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. | 7 days |
| Tissue Integrity | 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. | 7 days |
| Quality of Life Questionnaire EQ5D3L | 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. | 12 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Wound Volume | Median | Standard Deviation | mm^3 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Pain Questionnaire | 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. | Posted | Median | Standard Deviation | Score on a scale | 12 weeks |
|
|
|
| Secondary | Quality of Life Questionnaires SF-12 | 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. | Posted | Median | Standard Deviation | Score on scale | 12 weeks |
|
|
|
| Secondary | Infection Rate | The number of wounds which develop an infection in the study period. | Posted | Number | Infection that developed per ulcer | Recorded at 12 weeks | Ulcers | Ulcers |
|
|
|
| Secondary | Minor Amputation Rate | The number of minor amputations of treated limbs in the study period. | Posted | Number | Index limb | Recorded at 12 weeks | Index limb | Index limb |
|
|
|
| Secondary | Local Perfusion Rate | 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. | Posted | Median | Standard Deviation | ml/ml/s | 7 days |
|
|
|
| Secondary | Tissue Integrity | 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. | Posted | Median | Standard Deviation | g/m^2h | 7 days |
|
|
|
| Secondary | Quality of Life Questionnaire EQ5D3L | 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. | Posted | Median | Standard Deviation | Score on a scale | 12 weeks |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
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| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |