Clinical trial to evaluate the efficacy and safety of investigational product in treating non-healing foot ulcers in subjects with diabetes mellitus

  • STATUS
    Recruiting
Updated on 25 March 2021

Summary

Clinical trial to evaluate the efficacy and safety of investigational product in treating non-healing foot ulcers in subjects with diabetes mellitus

Description

Clinical trial to evaluate the efficacy and safety of investigational product in treating non-healing foot ulcers in subjects with diabetes mellitus

Length of Subject enrollment: total of 24 weeks
$75 per visit for time and travel. May be compensated up to $1,500

Details
Condition Diabetic Foot Ulcers, Diabetes Mellitus Types I and II
Clinical Study IdentifierTX138783
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients diagnosed with Type I or Type 2 Diabetes with at least one chronic (present for at least one month and no more than 10 months), non-healing plantar neuropathic foot ulcer of 0.75 - 6.0cm on the midfoot or forefoot
Male or female 18 years or older
Diabetes T1 or T2 with HbA1c of <12% and a serum creatinine level of <3mg/dl
Comply with study procedures
At screening, at least one chronic non-healing target ulcer
Non healing as defined as <30% reduction in size in response to standard of care during the screening period
Partial-or-full skin thickness not involving bone, tendon, or capsule
No sign of infection or osteomyelitis
Whole ulcer predominantly on the plantar surface of the foot
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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