Trial Outcomes & Findings for Comparing Clinical Outcomes Using Two Insole Manufacture Techniques (NCT NCT05444192)
NCT ID: NCT05444192
Last Updated: 2025-05-23
Results Overview
To compare the changes in pain in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
114 participants
Primary outcome timeframe
Measured 4 times throughout the 12-week period that the participant is wearing the insoles: Baseline immediately after receiving intervention (insoles). 4 weeks after intervention. 8 weeks after intervention. And 12 weeks after intervention
Results posted on
2025-05-23
Participant Flow
Assessed for eligibility (n=118) Excluded (n=4) * Already has suitable insoles (n=2) * Not suitable for treatment with insoles (n=1) * Declined to participate (n=1)
Participant milestones
| Measure |
Insoles Manufactured From Foam-box Cast
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
Insoles Manufactured From Direct 3D Scan
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
57
|
|
Overall Study
COMPLETED
|
56
|
57
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Insoles Manufactured From Foam-box Cast
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
Insoles Manufactured From Direct 3D Scan
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Comparing Clinical Outcomes Using Two Insole Manufacture Techniques
Baseline characteristics by cohort
| Measure |
Insoles Manufactured From Foam-box Cast
n=57 Participants
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
Insoles Manufactured From Direct 3D Scan
n=57 Participants
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.0 years
n=5 Participants
|
50.0 years
n=7 Participants
|
50.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
56 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other (mixed)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · African
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Area of primary musculoskeletal pathology
Ankle
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Area of primary musculoskeletal pathology
First ray
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Area of primary musculoskeletal pathology
Forefoot
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Area of primary musculoskeletal pathology
Lower leg
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Area of primary musculoskeletal pathology
Midfoot
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Area of primary musculoskeletal pathology
Plantar heel / plantar fascia
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured 4 times throughout the 12-week period that the participant is wearing the insoles: Baseline immediately after receiving intervention (insoles). 4 weeks after intervention. 8 weeks after intervention. And 12 weeks after interventionTo compare the changes in pain in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.
Outcome measures
| Measure |
Insoles Manufactured From Foam-box Cast
n=56 Participants
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
Insoles Manufactured From Direct 3D Scan
n=57 Participants
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
|---|---|---|
|
Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain
12 weeks following intervention
|
78.13 units on a scale
Interval 53.75 to 92.97
|
78.75 units on a scale
Interval 53.75 to 93.75
|
|
Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain
8 weeks following intervention
|
72.50 units on a scale
Interval 49.53 to 84.38
|
78.13 units on a scale
Interval 54.06 to 85.0
|
|
Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain
4 weeks following intervention
|
72.50 units on a scale
Interval 57.19 to 84.38
|
78.13 units on a scale
Interval 48.13 to 84.38
|
|
Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain
Baseline
|
48.13 units on a scale
Interval 29.38 to 71.88
|
53.75 units on a scale
Interval 27.19 to 72.5
|
SECONDARY outcome
Timeframe: Measured 4 times throughout the 12-week period that the participant is wearing the insoles: Baseline immediately after receiving intervention (insoles). 4 weeks after intervention. 8 weeks after intervention. And 12 weeks after interventionTo compare the changes in foot function in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.
Outcome measures
| Measure |
Insoles Manufactured From Foam-box Cast
n=56 Participants
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
Insoles Manufactured From Direct 3D Scan
n=57 Participants
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
|---|---|---|
|
Foot Health Status Questionnaire (FHSQ) - Function Sub-domain
12 weeks following intervention
|
87.50 units on a scale
Interval 68.75 to 100.0
|
93.75 units on a scale
Interval 65.63 to 100.0
|
|
Foot Health Status Questionnaire (FHSQ) - Function Sub-domain
8 weeks following intervention
|
75.00 units on a scale
Interval 51.56 to 93.75
|
93.75 units on a scale
Interval 59.38 to 100.0
|
|
Foot Health Status Questionnaire (FHSQ) - Function Sub-domain
4 weeks following intervention
|
87.50 units on a scale
Interval 57.81 to 93.75
|
87.50 units on a scale
Interval 62.5 to 100.0
|
|
Foot Health Status Questionnaire (FHSQ) - Function Sub-domain
Baseline
|
68.75 units on a scale
Interval 43.75 to 87.5
|
62.50 units on a scale
Interval 37.5 to 90.63
|
SECONDARY outcome
Timeframe: Measured 4 times throughout the 12-week period that the participant is wearing the insoles: Baseline immediately after receiving intervention (insoles). 4 weeks after intervention. 8 weeks after intervention. And 12 weeks after interventionTo compare the changes in foot health in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.
Outcome measures
| Measure |
Insoles Manufactured From Foam-box Cast
n=56 Participants
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
Insoles Manufactured From Direct 3D Scan
n=57 Participants
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
|---|---|---|
|
Foot Health Status Questionnaire - Foot Health Sub-domain
12 weeks following intervention
|
60.00 units on a scale
Interval 25.0 to 81.88
|
72.50 units on a scale
Interval 25.0 to 85.0
|
|
Foot Health Status Questionnaire - Foot Health Sub-domain
8 weeks following intervention
|
46.25 units on a scale
Interval 25.0 to 69.38
|
72.50 units on a scale
Interval 25.0 to 85.0
|
|
Foot Health Status Questionnaire - Foot Health Sub-domain
4 weeks following intervention
|
42.50 units on a scale
Interval 25.0 to 72.5
|
60.00 units on a scale
Interval 25.0 to 85.0
|
|
Foot Health Status Questionnaire - Foot Health Sub-domain
Baseline
|
25.00 units on a scale
Interval 0.0 to 60.0
|
42.50 units on a scale
Interval 0.0 to 72.5
|
SECONDARY outcome
Timeframe: Measured 12 weeks after being fitted with insolesTo compare the patient satisfaction in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.
Outcome measures
| Measure |
Insoles Manufactured From Foam-box Cast
n=55 Participants
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
Insoles Manufactured From Direct 3D Scan
n=57 Participants
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
|---|---|---|
|
Orthotic and Prosthetic User Survey9-12 (Satisfaction With Device Survey)
|
69.48 units on a scale
Interval 64.59 to 74.36
|
76.35 units on a scale
Interval 71.84 to 80.86
|
SECONDARY outcome
Timeframe: Costs were calculated per participant from baseline until their completion of the trial at week 12.A differential cost analysis was undertaken. This involved calculating the total cost for each participant using a calculation of transit costs, staff time, and physical resources for each participant throughout their time in the trial.
Outcome measures
| Measure |
Insoles Manufactured From Foam-box Cast
n=57 Participants
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
Insoles Manufactured From Direct 3D Scan
n=57 Participants
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
|---|---|---|
|
Differential Cost Analysis
|
55.46 cost in pounds and pence per participant
Interval 51.28 to 60.36
|
44.94 cost in pounds and pence per participant
Interval 39.98 to 48.12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured from baseline until completion of the trial at week 12Patients will keep a diary of daily wear time in hours, in accordance with prior publications on measuring Orthotic Adherence. The minimum threshold for adherence is \>21 hours per week
Outcome measures
| Measure |
Insoles Manufactured From Foam-box Cast
n=56 Participants
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
Insoles Manufactured From Direct 3D Scan
n=57 Participants
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
|---|---|---|
|
Tertiary Outcome Measure - Hours of Insole Wear Time Per Day
|
5.08 Hours
Interval 4.66 to 5.5
|
6.09 Hours
Interval 5.68 to 6.51
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured from baseline to completion of the trial at 12 weeks, for each participantDropout rate = n dropout at end of trial
Outcome measures
| Measure |
Insoles Manufactured From Foam-box Cast
n=57 Participants
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
Insoles Manufactured From Direct 3D Scan
n=57 Participants
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
|---|---|---|
|
Tertiary Outcome Measure - Dropout Rate
|
2 Participants
|
0 Participants
|
Adverse Events
Insoles Manufactured From Foam-box Cast
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Insoles Manufactured From Direct 3D Scan
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Insoles Manufactured From Foam-box Cast
n=57 participants at risk
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
Insoles Manufactured From Direct 3D Scan
n=57 participants at risk
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Advenrse event
|
12.3%
7/57 • Number of events 7 • 14 months
|
3.5%
2/57 • Number of events 2 • 14 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place