Health Condition 1: null- Adult Patients with Diabetic foot ulcer
Conditions
Interventions
Intervention1: Wound healing potential of dressing with Nitric Oxide patch: Use one nitrous oxide patch during Visit 02, 03, 04, 05, 06, 07, 08, 09 apply in wound topically
Control Intervention1: Not
Sponsors
Cologenesis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Normal, healthy, adult, male and female human patients of age between 18-65 years with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 29.99 kg/m2 2.Capacity of attending the visits at the research site. 3.Confirmed diagnosis of Diabetic Mellitus type 1 or 2 according to the Guidelines from the American Diabetes Association (ADA). 4.Presence of 1 or more Diabetic Foot Ulcer, less than 15cm in its biggest 5.Diameter, with a Texas University score 6.Glycosylated hemoglobin (HbA1c) of 7.At least one wound that is/has: Wagner grade 1 or superficial 2 (without bone, tendon or joint exposure), duration of at least 1 month, no clinical signs of infection or osteomyelitis, per original protocol, closed per Amendment #1, closed 8.Located on the foot, distal to malleoli. 9.Serum creatinine of <3.0mg/dl.
Exclusion criteria
Exclusion criteria: 1.History of allergy or hypersensitivity reactions to Nitric oxide or any related compound at any dose. 2.Unconfirmed Diabetic Mellitus diagnosis. 3.Evidence of allergy or known hypersensitivity to Nitric Oxide or its inactive ingredients. 4.Any pathology that, based on the judgment of the researcher, could alter the course of Diabetic Foot Ulcer (neoplasias, immunological disorders, etc). 5.Renal insufficiency requiring dialysis treatment. 6.Diabetic Foot Ulcer with a Texas score 2. 7.Infected Diabetic Foot Ulcer with clinical or paraclinical findings suggesting osteomyelitis. 8.Critical ischemia of Ischemic Limb diagnosed by Doppler ultrasound and defined by ankle/arm index 0.5. 9.Clinical findings suggesting complicated venous insufficiency of Ischemic Limb. 10.Distal necrosis of the limb with the ulcer. 11.Pregnant or breastfeeding women. 12.Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study. 13.Refusal to give informed consent. participated in another clinical trial within 30 days prior to consent, 14.Active Charcot deformity of the study foot (i.e. erythematous, warm, edematous and actively remodeling) 15.Receiving radiation or chemotherapy of any kind, 16.Known or suspected malignancy of current ulcer, 17.An active malignant disease, 18.Receiving hemo- or peritoneal dialysis, 19.Sickle cell anemia or Raynauds syndrome, 20.Diagnosis of autoimmune connective tissue disease, 21.Received a biologic agent, growth factor, xenograft or skin equivalent in the 30 days prior to consent, 22.Exposed bone, tendon or joint capsule in the study ulcer, 23.Currently receiving antibiotics (for any reason), or 24.Taking medications considered to be immune system modulators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To monitor the Efficacy and safetyTimepoint: Visit 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11 | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDrRajakumarPN
Bowring and Lady Curzon Hospitals
Outcome results
None listed