Diabetes
Conditions
Keywords
Diabetic Foot, Ulcer healing, Medical device to increase blood flow in foot
Brief summary
The investigators hypothesise that use of a medical device, that increases blood flow to the foot, will speed up ulcer healing in symptomatic diabetes
Detailed description
Diabetes affects approximately 347 million people worldwide, and by 2030 the WHO projects that diabetes will be the 7th leading cause of death. Diabetic foot ulcers are estimated to occur in 15% of all patients with diabetes, often co-existing with neuropathy and peripheral vascular disease which compromise the limb's ability to heal. Foot infections in this cohort are common, and diabetic foot ulcers serve as a portal for infective organisms to enter the body. Unchecked, infection can spread contiguously to involve underlying tissues, including bone. A diabetic foot infection is often the pivotal event leading to gangrene and lower extremity amputation. Diabetes accounts for over one million leg amputations every year, and represents 60% of all amputations in developed countries. Due to the potential for rapid progression of infection, and the gravity of potential complications, diabetic foot problems are handled aggressively in the community, with a low threshold for referral to secondary care. Out-patient clinics involve a multidisciplinary team of clinicians, podiatrists and vascular surgeons. Good foot care is taught to all diabetic patients, and treatment with antibiotics, debridement and revascularisation should occur as a matter of urgency where appropriate. The device to be tested mimics the effect of walking by making the foot twitch- it increases blood flow to the limb and exercises the leg muscles. It is hypothesised that increasing blood flow to the limb, much as surgical revascularisation, will aid the legs ability to heal and fight infection. After training, it can be used by patients on themselves and is suitable for out-patient therapy. The investigators wish to evaluate both the short- and longer-term effects of a neuromuscular stimulator on diabetic foot ulceration as a therapeutic intervention.
Interventions
DEVICEGEKO device
Placed on the lateral aspect of the knee, when activated it causes the leg to twitch
OTHERBest Medical Therapy
Seen in outpatient clinic for wound care and ongoing advice
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18+ years old * Type 2 diabetes on best medical therapy * Active foot ulceration, present \<3 months
Exclusion criteria
* Pregnancy * Pacemaker * Metal implants in the legs (below knee)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Day Until 50% Healing of Leg Ulcer | 8 weeks | Time to 50% healing of leg ulcer, as measured by volume (3D camera) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (PAID, EQ5D, VAS, SF-12) | 6 weeks | Improvement in quality of life questionnaire values, comparing baseline to 6 weeks with treatment PAID (Problem Areas in Diabetes) - score 0-80, 0 is no problem, 80 is serious problem EQ5D (standardised instrument for generic quality of life score, https://en.wikipedia.org/wiki/EQ-5D) - combination of different dimensions of health to form an overall index, 1.0 for a perfect state of health, with 0 on the scale representing the state of being dead VAS (visual analogue scale) - For pain intensity, the scale is anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100) SF 12 (short form 12) - weighted and summed to provide easily interpretable scales for physical and mental health, the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Device Medical therapy | 4 |
| Device As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week. | 4 |
| Total | 8 |
Baseline characteristics
| Characteristic | Device | Total | No Device |
|---|---|---|---|
| Age, Continuous | 69.5 years | 67 years | 65 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 4 participants | 8 participants | 4 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
Primary
Number of Day Until 50% Healing of Leg Ulcer
Time to 50% healing of leg ulcer, as measured by volume (3D camera)
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Device | Number of Day Until 50% Healing of Leg Ulcer | 55 Days | Standard Error 5 |
| Device | Number of Day Until 50% Healing of Leg Ulcer | 30 Days | Standard Error 5 |
Secondary
Quality of Life (PAID, EQ5D, VAS, SF-12)
Improvement in quality of life questionnaire values, comparing baseline to 6 weeks with treatment PAID (Problem Areas in Diabetes) - score 0-80, 0 is no problem, 80 is serious problem EQ5D (standardised instrument for generic quality of life score, https://en.wikipedia.org/wiki/EQ-5D) - combination of different dimensions of health to form an overall index, 1.0 for a perfect state of health, with 0 on the scale representing the state of being dead VAS (visual analogue scale) - For pain intensity, the scale is anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100) SF 12 (short form 12) - weighted and summed to provide easily interpretable scales for physical and mental health, the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health
Time frame: 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Device | Quality of Life (PAID, EQ5D, VAS, SF-12) | PAID | 22.8 units on a scale | Standard Deviation 14 |
| No Device | Quality of Life (PAID, EQ5D, VAS, SF-12) | EQ5D | .54 units on a scale | Standard Deviation 0.4 |
| No Device | Quality of Life (PAID, EQ5D, VAS, SF-12) | VAS | 58 units on a scale | Standard Deviation 13 |
| No Device | Quality of Life (PAID, EQ5D, VAS, SF-12) | SF-12 | 82.1 units on a scale | Standard Deviation 12 |
| Device | Quality of Life (PAID, EQ5D, VAS, SF-12) | EQ5D | .7 units on a scale | Standard Deviation 0.2 |
| Device | Quality of Life (PAID, EQ5D, VAS, SF-12) | VAS | 60 units on a scale | Standard Deviation 14 |
| Device | Quality of Life (PAID, EQ5D, VAS, SF-12) | SF-12 | 67 units on a scale | Standard Deviation 9 |
| Device | Quality of Life (PAID, EQ5D, VAS, SF-12) | PAID | 13 units on a scale | Standard Deviation 1 |
| Device (Week 0) | Quality of Life (PAID, EQ5D, VAS, SF-12) | VAS | 37 units on a scale | Standard Deviation 38 |
| Device (Week 0) | Quality of Life (PAID, EQ5D, VAS, SF-12) | EQ5D | .18 units on a scale | Standard Deviation 0.4 |
| Device (Week 0) | Quality of Life (PAID, EQ5D, VAS, SF-12) | SF-12 | 66 units on a scale | Standard Deviation 14 |
| Device (Week 0) | Quality of Life (PAID, EQ5D, VAS, SF-12) | PAID | 21.2 units on a scale | Standard Deviation 7 |
| Device (Week 6) | Quality of Life (PAID, EQ5D, VAS, SF-12) | SF-12 | 72 units on a scale | Standard Deviation 11 |
| Device (Week 6) | Quality of Life (PAID, EQ5D, VAS, SF-12) | EQ5D | .4 units on a scale | Standard Deviation 0.4 |
| Device (Week 6) | Quality of Life (PAID, EQ5D, VAS, SF-12) | PAID | 17.3 units on a scale | Standard Deviation 14 |
| Device (Week 6) | Quality of Life (PAID, EQ5D, VAS, SF-12) | VAS | 55 units on a scale | Standard Deviation 23 |