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NCT04605900
Impact of Therapeutic Footwear and Plantar Orthoses on Diabetic Neuropathic Foot in Quality of Life and Functionality
NA trial testing Orthopedic Footwear in Diabetes Mellitus, Type 2 in 43 participants. Completed in 21 May 2018.
4 January 2018
Quick facts
| Lead sponsor | Universidade do Algarve |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 43 |
| Start date | 13 March 2017 |
| Primary completion | 4 January 2018 |
| Estimated completion | 21 May 2018 |
| Sites | 1 location across Portugal |
Drugs / interventions tested
- Orthopedic Footwear
- Standard Footwear
- Plantar Orthoses
- Education on foot self-care
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
- Diabetic Peripheral Neuropathy — all drugs for Diabetic Peripheral Neuropathy →
Sponsor
Universidade do Algarve
Who can join
Adults 40 to 80, any sex, with Diabetes Mellitus, Type 2 or Diabetic Peripheral Neuropathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study determines the effectiveness of plantar orthoses and custom-made orthopedic footwear in functional level and quality of life of persons with diabetes type 2 and diabetic peripheral neuropathy. This study is important due the loss of protective sensation, feet are vulnerable to minor trauma caused by plantar pressure as well as mechanical and thermal injuries. Thus, Plantar Orthoses become necessary to reduce PP and align the foot. Additionally, it is known that footwear is the most frequent cause of diabetic foot injury, since ulceration is frequently a consequence of the continuous trauma provoked by inadequate footwear. For a higher efficacy in the treatment of the foot, it is also necessary to use custom-made orthopedic footwear, indicated in the treatment of foot pathologies. The lack of studies that evaluate the impact of this treatment on clinical measures such as quality of life and functional level, led to the development of this study, comparing a standard treatment (standard footwear and plantar orthoses) with an optimal treatment suggested in diabetic foot guidelines (therapeutic footwear and plantar orthoses).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04605900
- Europe PMC full search
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Other Universidade do Algarve trials
Trials by the same sponsor.
- NCT07268274 — Metabolic Trajectories and Protein Intake in Long-Stay Ventilated Intensive Care Unit (ICU) Patients · active not recruiting
- NCT05918159 — Effects of Sarcopenia on General Health Status in Elderly: a Population-based Study · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04605900 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidade do Algarve
- Last refreshed: 30 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04605900.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing