Trial Outcomes & Findings for Extracorporeal Shockwave Therapy for Diabetic Foot Wounds (NCT NCT04042285)

Results Overview

Change in wound volume between study visits

Recruitment status

COMPLETED

Target enrollment

24 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-03-28

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	24
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Extracorporeal Shockwave Therapy for Diabetic Foot Wounds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Extracorporeal Shockwave Therapy n=24 Participants 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.
Age, Continuous	58.82 years STANDARD_DEVIATION 13.72 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	24 Participants n=5 Participants
Wound Volume	1071.14 mm^3 STANDARD_DEVIATION 1416.56 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Change in wound volume between study visits

Outcome measures

Outcome measures
Measure	Extracorporeal Shockwave Therapy n=22 Participants 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.
Wound Volume	1.16 cm^3 Interval -1.8 to 4.12

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Extracorporeal Shockwave Therapy n=24 Participants 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.
Pain Questionnaire	1 Score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Extracorporeal Shockwave Therapy n=24 Participants 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.
Quality of Life Questionnaires SF-12	59.78 Score on scale Standard Deviation 6.13

SECONDARY outcome

Timeframe: Recorded at 12 weeks

The number of wounds which develop an infection in the study period.

Outcome measures

Outcome measures
Measure	Extracorporeal Shockwave Therapy n=24 Ulcers 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.
Infection Rate	1 Infection that developed per ulcer

SECONDARY outcome

Timeframe: Recorded at 12 weeks

The number of minor amputations of treated limbs in the study period.

Outcome measures

Outcome measures
Measure	Extracorporeal Shockwave Therapy n=24 Index limb 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.
Minor Amputation Rate	2 Index limb

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Extracorporeal Shockwave Therapy n=24 Participants 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.
Local Perfusion Rate	28.85 ml/ml/s Standard Deviation 37.09

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Extracorporeal Shockwave Therapy n=24 Participants 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.
Tissue Integrity	21.53 g/m^2h Standard Deviation 12.93

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Extracorporeal Shockwave Therapy n=24 Participants 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.
Quality of Life Questionnaire EQ5D3L	0.81 Score on a scale Standard Deviation 0.44

Adverse Events

Extracorporeal Shockwave Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Louise Hitchman

Hull University Teaching Hospitals NHS Trust

Phone: 01482 311925

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place