Institutional Review Board, Hospital for Special Surgery
August 17, 2006
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Sherry Backus, PT, DPT, MA
Jonathan T. Deland, MD
Phillip Demp, DPM
Benjamin Heilman, MS
Mark Lenhoff, BS
Brian Pansy, BS
Jinsup Song, DPM, PhD
One visit (without follow-up) will be conducted to evaluate the relationship between foot structure and function. Sixty subjects with high arched (pes cavus), normal arched (rectus), and low arched (pes planus) feet will be recruited from September 2006 through August 2008 for a study conducted at the Hospital for Special Surgery.
Twenty additional subjects with Diabetes and hallux valgus will be recruited at our collaborating institution, Temple University.
All subjects may be either male or female, from any ethnic or racial group, be from 21 to 80 years of age, and must review and sign the informed consent after the study has been thoroughly explained by a study personnel member. Children will not be recruited because their pedal structures are still developing which would be a confounding variable for this investigation. Group1 will have (1) a previous diagnosis of diabetes either type 1 or type 2, (2) a previous diagnosis of hallux valgus (HV) with an intermetatarsal angle > 15°, (3) previous dorsoplantar X-rays within one year of study entry, (4) the ability to walk independently, (5) no current cardiovascular or neuromusculoskeletal disease that would obviate participating in the walking portion of this protocol. Groups 2, 3, and 4 will have (1) no current symptoms of pain, (2) no other symptoms suggesting a pathology involving the foot and ankle, and (3) no HV or other visible pedal deformities (e.g. hammertoes). In addition group 2 (pes planus) will have (1) a resting calcaneal stance position (RCSP) > 4° of valgus, and (2) a forefoot to rearfoot relationship (FF-RF) >= 5° of varus. Group 3 (rectus) will have (1) a RCSP between 0° and 2° of valgus, and (2) a FF-RF between 0° and 4° of varus. Group 4 (pes cavus) will have (1) a RCSP > 1° of varus and (2) a FF-RF > 1° of valgus.
Subjects in all groups will be excluded if they (1) cannot walk independently, (2) have uncontrolled cardiovascular or neuromusculoskeletal disease that would obviate participating in the walking portion of this protocol, (3) had previous lower extremity surgery that has not completed the rehabilitation process (< 1 year post op), (4) had any surgery involving the foot.
Howard J. Hillstrom, PhD