Diabetic Foot Ulcer Clinical Trial
Official title:
Wound Healing Effects of HO/03/03 In Patients With Diabetic Neuropathic Plantar and Venous Ulcers, Pilot Study.
This is a multicenter pilot study to assess the healing effects of HO/03/03 on diabetic
neuropathic plantar and venous ulcers.
HO/03/03 action mechanism involves the manipulation of keratinocyte and fibroblast migration
and differentiation at the wound area.
- The primary end point of this study is assessment of safety in treating with HO/03/03
and the efficacy of the drug to promote wound closure of chronic wounds.
- The secondary end points are assessment time to closure and healing rate for the
measurement of wound healing progression.
This is a multicenter pilot study to assess the healing effects of HO/03/03 on diabetic
neuropathic plantar and venous ulcers.
Pretreatment phase: During a pretreatment phase that will last up to 14 days, all patients
will receive the conventional treatment once a day at the discretion of the investigator.
All wounds will be morphologically monitored by photo documentation daily and measurements
of wound area once a week.
Initial study visit: patients will begin treatment after completing all necessary demands in
pre-treatment phase or after ruling out of all exclusion criteria. All wounds will be
cleaned from previous treatment by surgical debridement and irrigation (saline).
Treatment phase: Following the pre-treatment phase, wounds will be treated topically with
HO/03/03 for 30 days. During this 30 day phase, patients will receive daily treatments with
HO/03/03 either at home by a certified nurse or at the clinic. Wounds will be monitored by
certified medical staff member as well as photo documentation. Then application of the
treatment followed by a 15-minute rest. Finally wound will be dressed with a fresh dressing
and monitoring of any adverse events.
Patients will be administered HO/03/03 in addition to weight off-load Once a week wounds
will be monitored by a physician: wounds size will be determined and documented. Patients
will be evaluated for pain sensation at the wound area by filling a pain scoring
questionnaire.
Twice during the experiment patients will undergo blood profile, HbA1c, blood glucose, and
urine samples testing at the initial and terminating visits.
At the conclusion of the treatment phase the following will be completed:
- A physical examination;
- Collection of all blood and urine samples for clinical laboratory tests (dip sticks);
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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