Health Trials

Clinical Study in Adult Patients With Purulent-inflammatory Processes of the Skin and Soft Tissues, Phase I-II of the Wound Process

ConditionsDiabetic Foot InfectionsChronic Venous Insufficiency
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorResearch Institute for Physical Chemical Problems of the Belarusian State University

About this trial

The purpose of this study is to estimate efficiency, tolerance, safety of "Foscelantan, medicinal plate 4.0x5.0 cm in package No. 1" among adult patients who have purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome or chronic venous insufficiency, phase I-II of the wound process.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The presence of purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome (Main diagnosis: Diabetes mellitus type I or II, clinical metabolic compensation/subcompensation, class I - II according to the Wagner classification) or chronic venous insufficiency (Main diagnosis: Varicose veins dilatation of the veins of the lower extremities, class C6 according to the CEAP classification), phase I-II of the wound process

The size of the ulcerative defect is from 1 cm² to 20 cm²

Secondary type of wound healing

Absence of exposed bones and tendons in the wound

Disqualifiers

Individual intolerance or hypersensitivity reactions to the components of the drug Foscelantan

Neuroischemic form of diabetic foot syndrome

The presence of serious concomitant pathology (severe form of renal and hepatic failure, systemic connective tissue diseases, severe cardiovascular insufficiency), history and current mental illness

The need to constantly take drugs from the list of prohibited therapies

Trial design

Design model

Parallel

Treatments tested in this trial

  • Foscelantan

    Drug

    "Foscelantan, medicinal plate 4.0x5.0 cm in package No. 1" produced by UNITEHPROM BSU, Republic of Belarus

  • Povidon-iodine

    Drug

    Povidone-iodine solution 100 mg/ml produced by BelAseptika CJSC, Republic of Belarus

Treatment groups

224 Participants
are divided into 4 treatment groups
Group A: Patients with the neuropathic form. Treatment with FoscelantanExperimental treatment 1 intervention
Group B: Patients with the neuropathic form. Treatment with Povidone-iodineActive comparator 1 intervention
Group C: Patients with chronic venous insufficiency. Treatment with FoscelantanExperimental treatment 1 intervention
Group D: Patients with chronic venous insufficiency. Treatment with Povidone-iodineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with trophic ulcers cured

Number of patients cured

Time frame
15 days

Secondary outcomes

1

percentage reduction in the non-epithelialized area of the wound surface in relation to the initial one

Additionally, the percentage reduction in the non-epithelialized area of the wound surface relative to the original will be calculated, determined by digital non-contact planimetry during dressing changes. This indicator will be assessed using a digital camera and image analysis software

Time frame
15 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Research Institute for Physical Chemical Problems of the Belarusian State University

Lead sponsor

Vitebsk Regional Clinical Hospital

Collaborator

Unitary Enterprise UNITEHPROM BSU

Collaborator

The 10th Minsk City Clinical Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: