Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04093635
Other study ID # VAC in DFUs
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 2019
Est. completion date January 2021

Study information

Verified date September 2019
Source Assiut University
Contact Abdelrahman Ibrahim
Phone 01009842539
Email abdoibrahim93@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

• The aim of this study will be to assess negative pressure wound therapy in treating diabetic foot ulcers.


Description:

Diabetic Foot ulcers are a major cause of admission in diabetic patients, and comprise a disproportionately high number of hospital days because of multiple surgical procedures and prolonged length of stay in Hospital.

The improvement in diabetes therapy and the reinforcement of guidelines have reduced the amputation rate. The approach to diabetic foot ulcers has allowed the availability of several medical options to ensure the best local condition and wound healing.

Negative-pressure wound therapy is a non-invasive therapy system that employs a controlled negative pressure using a vacuum device to promote wound healing by removing fluid from open wounds through a sealed dressing or a foam dressing connected to a container.

An earlier study has shown that NPWT reduced the need for subsequent amputations in a 6-month follow-up period. This reflects the importance of this device in management of DFUs and prevents its complications.

As most of the diabetic wounds present with infection, the success of NPWT is still highly dependent upon the adequacy of surgical debridement and antimicrobial coverage.

NPWT provides a moist wound environment ideal for re-epithelialization, growth factor action, angiogenesis, and granulation promotion.

Edema reduction produced by NPWT decreases interstitial pressure and positively promoting wound vessel formation and improving wound circulation and lymphatic drainage, increasing the availability of nutrients, oxygen and antibiotic therapy in the wound area. Some studies showed that NPWT promotes an improvement of balance between proteases and their inhibitors and influences cytokine modulation and promotes a positive wound environment.

Accurate classification of diabetic foot ulcers according to Wagner's classification of ulcers is essential for inter-clinician communication, assessment of healing tendency during management by NPWT.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date January 2021
Est. primary completion date November 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Acute and chronic diabetic wounds, pressure ulcers.

- Wagener's Grade I superficial diabetic ulcer.

- Wagener's Grade II after surgical debridement and an appropriate antibiotic therapy.

- Ischemic wounds after revascularization.

Exclusion Criteria:

- - Wagener's Grade III, osteomyelitis and Charcot's joint septic arthritis.

- Wagener's Grade IV, localized gangrene e.g. toe ,heel.

- Wagener's Grade V, extensive gangrene involving the whole foot.

- Septicemia. .

- Gas forming organism.

- Wounds resulting from venous insufficiency.

- Peripheral vascular disease (absent distal pulse).

- Patients being treated with corticosteroids, immunosuppressive drugs or chemotherapy

- Any other serious pre-existing cardiovascular, pulmonary and immunological disease.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Negative Pressure Wound Therapy
VAC was applied by placing sterile pads in two layers with a 16Fr Ryle's tube placed between the two layers and then the wound was sealed by a sterile transparent polyurethane sheet. The tube was connected to a wall-mounted suction device and the pressure will be set at -125 mmHg Mode of NPWT. This dressing will be changed every 72 hrs

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (5)

Borys S, Hohendorff J, Koblik T, Witek P, Ludwig-Slomczynska AH, Frankfurter C, Kiec-Wilk B, Malecki MT. Negative-pressure wound therapy for management of chronic neuropathic noninfected diabetic foot ulcerations - short-term efficacy and long-term outcomes. Endocrine. 2018 Dec;62(3):611-616. doi: 10.1007/s12020-018-1707-0. Epub 2018 Aug 11. — View Citation

Hu X, Lian W, Zhang X, Yang X, Jiang J, Li M. Efficacy of negative pressure wound therapy using vacuum-assisted closure combined with photon therapy for management of diabetic foot ulcers. Ther Clin Risk Manag. 2018 Oct 25;14:2113-2118. doi: 10.2147/TCRM.S164161. eCollection 2018. — View Citation

Iheozor-Ejiofor Z, Newton K, Dumville JC, Costa ML, Norman G, Bruce J. Negative pressure wound therapy for open traumatic wounds. Cochrane Database Syst Rev. 2018 Jul 3;7:CD012522. doi: 10.1002/14651858.CD012522.pub2. Review. — View Citation

James SMD, Sureshkumar S, Elamurugan TP, Debasis N, Vijayakumar C, Palanivel C. Comparison of Vacuum-Assisted Closure Therapy and Conventional Dressing on Wound Healing in Patients with Diabetic Foot Ulcer: A Randomized Controlled Trial. Niger J Surg. 2019 Jan-Jun;25(1):14-20. doi: 10.4103/njs.NJS_14_18. — View Citation

Liu S, He CZ, Cai YT, Xing QP, Guo YZ, Chen ZL, Su JL, Yang LP. Evaluation of negative-pressure wound therapy for patients with diabetic foot ulcers: systematic review and meta-analysis. Ther Clin Risk Manag. 2017 Apr 18;13:533-544. doi: 10.2147/TCRM.S131193. eCollection 2017. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Management of diabetic foot ulcers. Assessment role of negative pressure wound therapy in treating diabetic foot ulcers. one year
See also
  Status Clinical Trial Phase
Recruiting NCT04497805 - Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers Phase 2
Withdrawn NCT03675269 - Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer: N/A
Completed NCT04624516 - Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence N/A
Not yet recruiting NCT06439667 - VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING PLANTAR WOUND HEALING
Recruiting NCT05608187 - Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers Phase 2
Not yet recruiting NCT06437028 - Evaluating the Efficacy of Perinatal Membrane Allografts for the Treatment of Diabetic Foot Ulcers. N/A
Not yet recruiting NCT06278935 - Lifestyle Tailored Offloading for Diabetic Foot Ulcers N/A
Withdrawn NCT05024656 - AmnioExcel® Plus vs SOC in the Management of Diabetic Foot Ulcers N/A
Terminated NCT02202668 - Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers N/A
Terminated NCT01966380 - Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia Phase 2
Completed NCT01951768 - Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection Phase 4
Completed NCT01657474 - Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers N/A
Active, not recruiting NCT00389636 - TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers N/A
Completed NCT01181440 - Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers Phase 3
Enrolling by invitation NCT05888259 - Plantar Pressure Distribution in Diabetic Foot Ulcer N/A
Completed NCT04054804 - Digital Foot Check by Using the D-Foot, a New Software
Not yet recruiting NCT05877378 - Efficacy of PICO Single-use System in Chronic Ulcers N/A
Recruiting NCT06037369 - The Short Message-based Customized Standardized N/A
Completed NCT03312595 - Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) N/A
Recruiting NCT04564443 - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot N/A