Diabetic Foot, Wound
Conditions
Keywords
Diabetic Foot Wound
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.
Interventions
DEVICEExtracorporeal shockwave therapy in addition to standard care
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.
Sponsors
University of Hull
Hull University Teaching Hospitals NHS Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Volume | 12 weeks | Change in wound volume between study visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Extracorporeal Shockwave Therapy |
|---|---|
| Age, Continuous | 58.82 years STANDARD_DEVIATION 13.72 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United Kingdom | 24 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 20 Participants |
| Wound Volume | 1071.14 mm^3 STANDARD_DEVIATION 1416.56 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Wound Volume
Change in wound volume between study visits
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Extracorporeal Shockwave Therapy | Wound Volume | 1.16 cm^3 |
Secondary
Infection Rate
The number of wounds which develop an infection in the study period.
Time frame: Recorded at 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extracorporeal Shockwave Therapy | Infection Rate | 1 Infection that developed per ulcer |
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.
Time frame: 7 days
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Extracorporeal Shockwave Therapy | Local Perfusion Rate | 28.85 ml/ml/s | Standard Deviation 37.09 |
Secondary
Minor Amputation Rate
The number of minor amputations of treated limbs in the study period.
Time frame: Recorded at 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extracorporeal Shockwave Therapy | Minor Amputation Rate | 2 Index limb |
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Extracorporeal Shockwave Therapy | Pain Questionnaire | 1 Score on a scale | Standard Deviation 0 |
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Extracorporeal Shockwave Therapy | Quality of Life Questionnaire EQ5D3L | 0.81 Score on a scale | Standard Deviation 0.44 |
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Extracorporeal Shockwave Therapy | Quality of Life Questionnaires SF-12 | 59.78 Score on scale | Standard Deviation 6.13 |
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.
Time frame: 7 days
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Extracorporeal Shockwave Therapy | Tissue Integrity | 21.53 g/m^2h | Standard Deviation 12.93 |