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Completed

NCT Number: NCT01912092

Askina Calgitrol Paste Diabetic Foot Ulcers

The purpose of this study is to assess the efficacy of Askina® Calgitrol® Paste in reducing local infection in subjects treated for mildly infected Diabetic Foot Ulcers (DFU) with Askina® Calgitrol® Paste.

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Key information

Conditions

Diabetic Foot Ulcer (DFU) Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetic Foot and metabolic diseases clinic, Milan, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject older than 18 years old
  • Provision of written consent by the subject themselves
  • Subjects with a Texas stage I-B wound below the malleolus: superficial and infected (Wagner-Armstrong classification system).
  • Subjects with a mildly infected wound according to the Infectious Diseases Society of America (IDSA).
  • Size of wound >2 cm2.
  • Absence of ischaemia of the lower limb as assessed by :
  • Transcutaneous oxygen pressure (TcPO2) > 30 mmHg.
  • Toe pressure > 50 mmHg.
  • Ankle pressure > 70 mmHg.
  • Capable of following Study instructions.
  • Compliant with treatment and in particular with off-loading regime.
  • Stable management of their diabetes as defined by an HbA1C (%) of 12%

Exclusion criteria

  • Subjects who are <18 years old.
  • Subjects with a documented sensitivity to alginates or silver.
  • Subjects taking a medication or using a device comprising silver.
  • Subjects already taking antibiotics before enrolment
  • Subjects undergoing dialysis.
  • Subjects using therapy known to be immune-compromising such as systemic anti-neoplastic drugs and/or systemic cortico-steriods.
  • Pregnancy
  • Breast-feeding
  • Currently participating in another clinical trial, or who have participated in another clinical trial in the last 6 weeks or who have previously taken part in this study

Treatment and study plan

Askina Calgitrol paste

Device

Primary outcomes

  1. Clinical signs of local infection (Presence of erythema, pain, tenderness, warmth or induration)

    Time frame: At day 0, day 2 and weekly in a period of a maximum of 6 weeks

    During each of the day 2 and weekly control visits, the investigator will observe the wound visually and assess it for signs of Clinical infection, using the Guidelines for Diabetic Foot Ulcer infection of the Infectious Diseases Society of America. The investigator will score the degree of infection of the wound according to a table adapted from the 8 items wound score for diabetic foot infections.

    In general, treatment with Askina Calgitrol Paste will be discontinued when local infection has resolved or when it was worsened since the last control visit. However, treatment of Askina Calgitrol Paste will continued after 4 weeks of treatment only if there are signs of improvement.

    The treatment period of Askina Calgitrol Paste will last a maximum of 6 weeks.

Secondary outcomes

  1. Adverse events or Adverse device related event

    Time frame: At day 2 and weekly in a period of a maximum of 6 weeks

  2. Evaluation of wound bed (necrosis, slough, granulation, epithelialisation)

    Time frame: At day 0, day 2 and weekly in a period of a maximum of 6 weeks

    It will be assessed visually by the investigator.

  3. Ease of use of Askina Calgitrol Paste

    Time frame: Daily or at every change of dressing, in a period of a maximum of 6 weeks

    Ease of application and removal of dressing will be assessed by the subject/subject's relatives and the investigator using a rating scale of 1 (very easy) to 5 (very difficult). Dressing change at home will be evaluated in a patient diary by the patient or the carer and dressing changes in the clinic by the investigator.

  4. Wound surface area

    Time frame: At day 0, day 2 and weekly in a period of a maximum of 6 weeks

    It will be measured by Visitrak Wound Measurement System at each clinic visit by the healthcare professional.

Sponsors and collaborators

Lead sponsor

BBraun Medical SAS

Industry

Registry information

Official study title

A NON-CONTROLLED PROSPECTIVE COHORT STUDY OF THE USE OF ASKINA® CALGITROL® PASTE + STANDARD OF CARE ON MILDLY INFECTED, NON-ISCHAEMIC DIABETIC FOOT ULCERS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2013
Registry last updated
Jul 31, 2015

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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