Negative pressure wound therapy
DeviceNPWT applied over wound without any adjuncts
NCT Number: NCT06832787
Singapore has one of the world's highest diabetes-related lower limb amputation rates in the world. Between 2008 - 2017, 4724/5306 (89.0%) of all major amputations and 6656/7227 (92.1%) of all toe/ray amputations performed in Singapore were for diabetic patients. Diabetic foot ulcers are generally slow to heal and poor wound management may lead to infection and subsequently major amputations. Hence, adequate wound care to achieve wound healing efficiently and effectively is of utmost importance.
In the investigators' clinical practice, Negative Pressure Wound Therapy has been the dressing of choice to aid wound closure and prevent infective complications. Drainage of wound exudates helps to reduce and prevent infection, promote granulation tissue proliferation and induce cell growth. When used in combination with dermal substitutes, graft uptake is improved by further promoting proliferation and encouraging tissue regeneration.
Wounds can also be closed surgically though primary closure, where the skin is closed and serves as a physical barrier against infection. The technique is not without its pros and cons. Primary closure may decrease healing time and reduce need for additional surgery, but these patients are also at risk of recurrent infection and may require more proximal amputation. These may be circumvented with delayed primary closure, which is the surgical closure of the amputation wound at a delayed timing after amputation. This gives the clinical team time to optimize the wound and ensure that there is no underlying infection prior to closure.
The experience of NPWT + Kerecis Omega 3 and delayed primary closure have been positive. To the investigators' current knowledge, there is only one case series reported for the use of fish skin graft in combination with NPWT for the treatment of acute pediatric wounds and two case series for the use of NPWT in diabetic foot wound that has undergone surgical closure. The proposed study would be the first RCT to evaluate effects of combination therapy in both open and closed diabetic foot ulcers.
Interested in participating?
Request Info21 year–100 year
All sexes
Interventional
Not applicable
Sengkang General Hospital, Singapore
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
NPWT applied over wound without any adjuncts
Kerecis Omega3 Wound Dressing is derived from fish skin and is used as a dermal substitute.
Delayed primary closure with local flap to close wound
Time frame: 12 weeks post-intervention
100% Wound Closure defined as re-epithelization without any need for dressing
Time frame: Up to 12 weeks post-intervention
Time (in days) taken from intervention to 100% wound closure
Time frame: From time of intervention to 12 weeks post-intervention
Pain score is measured using the Wong-Baker FACES® Pain Rating Scale. Participants will be asked at baseline, and at 4, 8 and 12 weeks subsequently. 0 corresponds to "no pain", and 10 corresponds to "worst pain imaginable".
Time frame: Up to 12 weeks post-intervention
Occurrence of any infection at index wound during follow-up period is recorded
Time frame: Up to 12 weeks post-intervention
Occurrence of further minor amputation at index wound during follow-up period is recorded
Time frame: Up to 12 weeks post-intervention
Occurrence of major amputation at index limb during follow-up period is recorded
Time frame: Up to 12 weeks post-intervention
Occurrence of death during follow-up period is recorded
Contact information is provided by the study sponsor or research team.
Singapore General Hospital
Other
Prospective, Multi-Center Randomized Controlled Trial for the Combinational Use of Negative Pressure Wound Therapy (NPWT) for the Treatment of Diabetic Wounds
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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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