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Completed

NCT Number: NCT01111695

Evaluation of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs

In this open study, the primary objective is to study the efficacy and clinical outcome of the chronic wounds treated with this preparation for 8 weeks on 30 adults. Evaluation will be based on standardised photographs and clinical data.

The secondary objectives are to evaluate the tolerance and side effects of the honey based preparation in the management of chronic wounds.

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Key information

Conditions

Leg Ulcer Cardiovascular Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Home Care Service of the canton of Geneva

Geneva, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult
  • Chronic wounds due to arterial or venous insufficiency stages 1 to 3 and difficult to heal with the usual treatments and
  • Written informed consent

Exclusion criteria

  • Refuse to give written informed consent.
  • Patient suffering from mental disorder that may interfere with the treatment.
  • Known allergy or intolerance to any of the products used in the formulation.
  • Having received systemic antibiotics within 7 days of starting treatment with honey based formulation.
  • Arterial insufficiency stage IV of the lower limbs.

Treatment and study plan

ApisSept

Device

honey and ionic silver based dressing

Primary outcomes

  1. Granulation and /or epithelial tissue progression

    Time frame: 8 weeks

    Granulation and /or epithelial tissue progression as observed by standardised photography (colour-based and analysis of the wound).

Secondary outcomes

  1. Tolerance

    Time frame: 8 weeks

    Tolerance: Evaluate for signs and symptoms of irritation,inflammation, allergy or pain in and around the treated zone by clinical observation.

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • Haute école de santé - Genève

Registry information

Official study title

Open Label Study (Phase 2) to Evaluate the Safety, Tolerance and Efficacy of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 27, 2010
Registry last updated
Sep 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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