Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.

NCT01011387 | Completed Results

• 1 other identifier: NPWT 01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

Primary objective

• To assess wound healing and granulation tissue formation when using the NPWT system Secondary objectives
• To investigate the pain level at dressing removal
• To visually check exudate removal
• To investigate the ease of use for the subject and care giver when using the NPWT system

Conditions

Diabetes; Foot Ulcers

Keywords

Diabetic foot ulcers

Outcome Measures

Primary Outcomes (1)

• Mean Change in Wound Area.

  Measured by tracing of wound and measured by planimeter.

  From baseline to maximum 4 weeks

Study Arms (1)

NPWT system

OTHER

Negative pressure wound therapy

Procedure: NPWT System; Device: NPWT system

Interventions

NPWT system PROCEDURE

Dressing change 3 times per week

NPWT system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic foot ulcers (DFUs) including post amputation wounds associated with diabetes suitable for Negative Pressure Wound Therapy according to the investigator's judgment
• cm2 ≤ Wound size ≤ 200 cm2
• Male or female, 18 years and above
• Signed Informed Consent Form
• Subject understands the written subject Information

You may not qualify if:

• Need for frequent dressing changes, i.e.\<72 hours between the changes
• Dry wounds
• Critical ischemia (for wound healing) according to investigator's judgement
• Malignancy in the wound and/or wound margin
• Target ulcer previous not successfully treated with NPWT within 48 hours
• Poorly controlled diabetes according to investigators judgement.
• Osteomyelitis which has been left untreated
• Infection which has been left untreated
• Unexplored fistula
• \> 10% surface area necrotic tissue with eschar present after debridement
• High risk for bleeding complications
• Exposed major blood vessels, organs or nerves
• Current or within 3 months treatment with chemotherapy or irradiation
• Known hypersensitivity to the dressing material
• Expected technically impossible to seal the film to maintain a vacuum for treatment

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (2)

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Location

Norfolk & Norwich University Hospital

Norfolk,, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus; Foot Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetic Neuropathies

Results Point of Contact

• Title: Jenny Thorell
• Organization: Mölnlycke Health Care AB

jenny.thorell@molnlycke.com

0046 31 7223000

Study Officials

• Gerard Stansby, MD, Prof.

  Freeman Hospital, Newcastle upon tyne

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2009
• First Posted: November 11, 2009
• Study Start: January 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 21, 2012
• Results First Posted: March 21, 2012

Record last verified: 2012-03

Locations

GB (2)