Phase 2
Completed N=10
Clinical Evaluation of Direct Manufactured Prosthetic Sockets
Amputation
Source: ClinicalTrials.gov NCT01155024 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcomePrimary: Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting — 9; 8.7 score on scale — p=>0.4
Summary
The purpose of this study is to evaluate a new prosthetic socket construction technique in order to improve the quality of care to lower extremity amputees.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting |
9; 8.7 | >0.4 |
| SECONDARY Participant Socket Preference After Initial Fitting |
2; 0; 8 | — |
| SECONDARY Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket |
2; 4; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Be a lower extremity amputee longer than one year
- Be a consenting adult (at least 18 years or age or older)
- Albe to ambulate in current prosthesis without an aid (can, crutches or walker) for 30 minutes without rest
- Currently using a liner with prosthesis
- Be available during regular business hours for appointments
Exclusion Criteria
- An inability to give informed consent
- Presence of any sores, lacerations or rashes on the residual limb
- Impaired contra lateral foot
- Poor distal sensation
Data sourced from ClinicalTrials.gov (NCT01155024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.