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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPWT Only | Other | Control: Negative Pressure Wound Therapy only |
|
| NPWT + Kerecis | Active Comparator | Combinational Therapy of Negative Pressure Wound Therapy + application of Kerecis Omega 3 Wound Matrix |
|
| NPWT + Delayed Primary Closure with Local Flap | Active Comparator | Combinational Therapy of Delayed Primary Closure with Local Flap and Negative Pressure Wound Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Pressure Wound Therapy | Device | NPWT applied over wound without any adjuncts |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of 100% Wound Closure at 12 weeks | 100% Wound Closure defined as re-epithelization without any need for dressing | 12 weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Time in days taken to achieve complete wound closure | Time (in days) taken from intervention to 100% wound closure | Up to 12 weeks post-intervention |
| Change in Wong-Baker FACESĀ® Pain Rating Scale Score from Baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charyl Yap, B.Sc | Contact | +65 6576 7986 | charyl.yap.j.q@sgh.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Jack Kian Ch'ng | Singapore General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore General Hospital | Recruiting | Singapore | 169856 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36240798 | Background | Ciprandi G, Kjartansson H, Grussu F, Baldursson BT, Frattaroli J, Urbani U, Zama M. Use of acellular intact fish skin grafts in treating acute paediatric wounds during the COVID-19 pandemic: a case series. J Wound Care. 2022 Oct 2;31(10):824-831. doi: 10.12968/jowc.2022.31.10.824. | |
| 22561521 | Background | Aerden D, Vanmierlo B, Denecker N, Brasseur L, Keymeulen B, Van den Brande P. Primary closure with a filleted hallux flap after transmetatarsal amputation of the big toe for osteomyelitis in the diabetic foot: a short series of four cases. Int J Low Extrem Wounds. 2012 Jun;11(2):80-4. doi: 10.1177/1534734612446640. Epub 2012 May 4. |
| Label | URL |
|---|---|
| NPWT in closed foot wounds | View source |
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Due to Personal Data Protection Act.
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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| Kerecis | Device | Kerecis Omega3 Wound Dressing is derived from fish skin and is used as a dermal substitute. |
|
| Delayed primary closure with local flap | Device | Delayed primary closure with local flap to close wound |
|
Pain score is measured using the Wong-Baker FACESĀ® 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".
| From time of intervention to 12 weeks post-intervention |
| Occurrence of infection during study period | Occurrence of any infection at index wound during follow-up period is recorded | Up to 12 weeks post-intervention |
| Occurrence of further minor amputation during study period | Occurrence of further minor amputation at index wound during follow-up period is recorded | Up to 12 weeks post-intervention |
| Occurrence of major amputation during study period | Occurrence of major amputation at index limb during follow-up period is recorded | Up to 12 weeks post-intervention |
| Occurrence of death during study period | Occurrence of death during follow-up period is recorded | Up to 12 weeks post-intervention |
| Sengkang General Hospital | Recruiting | Singapore | Singapore |
|
| 11818842 | Background | Blume PA, Paragas LK, Sumpio BE, Attinger CE. Single-stage surgical treatment of noninfected diabetic foot ulcers. Plast Reconstr Surg. 2002 Feb;109(2):601-9. doi: 10.1097/00006534-200202000-00029. |
| 16890866 | Background | Berceli SA, Brown JE, Irwin PB, Ozaki CK. Clinical outcomes after closed, staged, and open forefoot amputations. J Vasc Surg. 2006 Aug;44(2):347-351; discussion 352. doi: 10.1016/j.jvs.2006.04.043. |
| 33344649 | Background | Zhang L, Weng T, Wu P, Li Q, Han C, Wang X. The Combined Use of Negative-Pressure Wound Therapy and Dermal Substitutes for Tissue Repair and Regeneration. Biomed Res Int. 2020 Dec 4;2020:8824737. doi: 10.1155/2020/8824737. eCollection 2020. |
| 34526864 | Background | Normandin S, Safran T, Winocour S, Chu CK, Vorstenbosch J, Murphy AM, Davison PG. Negative Pressure Wound Therapy: Mechanism of Action and Clinical Applications. Semin Plast Surg. 2021 Aug;35(3):164-170. doi: 10.1055/s-0041-1731792. Epub 2021 Sep 10. |
| 34916107 | Background | Riandini T, Pang D, Toh MPHS, Tan CS, Choong AMTL, Lo ZJ, Chandrasekar S, Tai ES, Tan KB, Venkataraman K. National Rates of Lower Extremity Amputation in People With and Without Diabetes in a Multi-Ethnic Asian Population: a Ten Year Study in Singapore. Eur J Vasc Endovasc Surg. 2022 Jan;63(1):147-155. doi: 10.1016/j.ejvs.2021.09.041. Epub 2021 Dec 14. |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |