- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03507478
An Evaluation of a Customized Insole to Provide Relief From Heel Pain Due to Plantar Fasciitis or General Heel Pain When Used in Footwear Over a Period of Four Weeks
Przegląd badań
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Arizona
-
Phoenix, Arizona, Stany Zjednoczone, 85029
- Thomas J. Stephens & Associates, Inc.
-
-
Texas
-
Richardson, Texas, Stany Zjednoczone, 75081
- Stephens & Associates, Inc.
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Subjects must be generally healthy and 18 to 65 years of age inclusive;
- Male subjects must have measured foot sizes between size 8.5 and 15. Female subjects must have measured foot sizes between size 8 and 10.5;
- Subjects must be willing to designate 2 pair of shoes with a maximum heel height of 1 ¼ inches, of either casual, work or type of sneakers, for approval of use during the trial. A maximum of 25% of subjects can be sneaker wearers. The 2nd pair of presented shoes must be of the same type. Subjects that wear shoes in the work category may qualify a single pair of shoes as long as the subject wears the same pair of shoes to work every day;
- Subjects must indicate that they currently have heel pain and that they experience heel pain at the end of the day. Subjects that have plantar fasciitis will be identified by the presence of acute pain in the morning upon taking their first steps;
- Subjects must report Heel pain of ≥20 mm to ≤90 mm at the end of their day [assessed on a 100 mm Visual Analog Scale (VAS), where 0=no pain and 100=worst pain possible] at baseline.
Exclusion Criteria:
- Subjects with heel pain due to recent heel spurs, stress fracture or other structural issues;
- Subjects with self-reported alcohol consumption that exceeds moderate consumption (>2 alcoholic beverages per day);
- Subjects with a self-reported history or suspicion of psychiatric disorder, alcohol or drug abuse, including, but not limited to: barbiturate, amphetamine, benzodiazepine, cocaine, opiate, methamphetamine, cannabis abuse;
Subjects that have received or used an Investigational New Drug in the past 30 days;
= Subjects that have been enrolled in the last two weeks or are currently participating in a product performance research study or any other type of research, marketing, or product performance study;
- Subjects who are nursing, pregnant, or planning to become pregnant during the course of the study (self-reported);
- Subjects who are employed or have family members employed by Market Research/Marketing Consulting, Manufacturing, Distribution, Retail or Marketing of any type of personal care product, drug product, or pharmaceutical;
- Subjects who have diabetes, circulatory problems, open wounds, and lack of sensation in their feet or any problems that would make insole wear uncomfortable or inappropriate;
- Subjects who wear physician-prescribed orthotic insoles or prescription shoes;
- Subjects who have had a traumatic injury to the lower extremity (deemed of non-overuse nature), which in the opinion of the examining Investigator would interfere with the study evaluations;
- Subjects whose condition requires surgery or other medical intervention or who have undergone foot back or knee surgery within the past 3 months or with any planned surgeries and/or invasive medical procedures during the course of the study;
- Subjects who are currently taking an opioid-based pain medication or have taken such medication within 2 months prior to Visit 1;
- Subjects who are taking any chronic pain medication (prescription or OTC) for at least 2 months, who do not agree to continue taking it at the same dose and regimen throughout the study;
- Subjects who have severely painful bunions, warts, corns and/or calluses, or severely overlapping toes, or lesions on the bottom of their foot;
- Subjects who have sensitivities or allergies to plastics or adhesives;
- Subjects who have conditions which in the opinion of the investigator preclude participation for scientific reasons of compliance, or for reasons of subject's safety;
- Subjects who have any condition that would make study participation inappropriate, as determined by the examining Investigator or designee;
- Subjects with a self-reported history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.), and/or radiation as determined by study documentation;
- Previous assignment to treatment during this study.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: BPI1000013
Subjects suffering from pain associated with plantar fasciitis or general heel pain
|
Foam insole
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Foot pain assessment of plantar fasciitis heel pain using the 100 mm VAS
Ramy czasowe: Up to 5 weeks (including screening)
|
VAS (Visual Analog Scale): 100 mm with 0 = no pain and 100 = Worst pain possible |
Up to 5 weeks (including screening)
|
Foot pain assessment of general heel pain using the 100 mm VAS
Ramy czasowe: Up to 5 weeks (including screening)
|
VAS (Visual Analog Scale): 100 mm with 0 = no pain and 100 = Worst pain possible |
Up to 5 weeks (including screening)
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
---|---|
Foot Comfort/Discomfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale
Ramy czasowe: Up to 4 weeks
|
Up to 4 weeks
|
Shoe/foot Fit with use in shoes is assessed utilizing a 7-point Likert scale
Ramy czasowe: Up to 4 weeks
|
Up to 4 weeks
|
Number of subjects with AEs
Ramy czasowe: Up to 5 weeks
|
Up to 5 weeks
|
Number of subjects with SAEs
Ramy czasowe: Up to 5 weeks
|
Up to 5 weeks
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 20102
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .